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.
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass IIZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceZavationClass II10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Products distributed as sterile may not have been adequately sterilized
- 2021-06-09FDA-DeviceMARVAO MEDICAL DEVICES LTD.Class IINexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
- 2021-06-09FDA-DeviceFlower Orthopedics CorporationClass IIT25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
- 2021-06-09FDA-DeviceK2M, IncClass IICascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
- 2021-06-09FDA-DeviceK2M, IncClass IICascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
- 2021-06-09FDA-DeviceK2M, IncClass IICascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
- 2021-06-09FDA-DeviceSignature Orthopedics Pty LimitedClass IILogical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Product mislabeled, with the incorrect product inside the package.
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