Category
Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-03-17FDA-DeviceMedtronic VascularClass IIMedtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Sterility may be compromised due to an unsealed pouch
- 2021-03-17FDA-DeviceMedtronic VascularClass IIMedtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Sterility may be compromised due to an unsealed pouch
- 2021-03-17FDA-DeviceMedtronic VascularClass IIMedtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Sterility may be compromised due to an unsealed pouch
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathr
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathr
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathros
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 2Level, 42mm Material Number: 66-242 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
- 2021-03-17FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class IICervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosi
Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision
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