Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 24 recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture.…
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bo…
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and…