Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-11-21FDA-DeviceStraumann Manufacturing, Inc.Class IINeodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Laser engraved label does not match with the item in the package
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-11-21FDA-DeviceBioFire Diagnostics, LLCClass II-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.
- 2018-11-21FDA-DeviceLuminex CorporationClass IIVERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
Potential to lead to a false negative results.
- 2018-11-21FDA-DeviceEspiner Medical LtdClass IIEspiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.
Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml
- 2018-11-21FDA-DevicebioMerieux, Inc.Class IIbioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Some eluates become colored because of remaining hemoglobin in the eluate.
- 2018-11-21FDA-DeviceArthrex, Inc.Class II3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
There is potential to break during use.
- 2018-11-21FDA-DeviceR82 A/SClass IIHeron toilet and bath chair Model 880505-01 & 880505-11
Replacement campaign on all units that have a gas spring head in aluminum.
- 2018-11-21FDA-DeviceMedtronic Sofamor Danek USA IncClass IIINFUSE Bone Graft X SMALL KIT REF 7510100
The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
- 2018-11-21FDA-DeviceStryker Medical Division of Stryker CorporationClass IIThe Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
- 2018-11-21FDA-DeviceStryker Medical Division of Stryker CorporationClass IIThe Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
- 2018-11-21FDA-DeviceAROA Biosurgery, LTD.Class IIOviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
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