Reported Jul 18, 2018 · Terminated
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in…
Cayenne Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cayenne Medical Inc. · 16597 N 92nd St Ste 101 · Scottsdale, AZ · 85260-1847
Is this the product you have?
- AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
- Lot codes and dates
- Item Number (Lot Number)
CM-2409 (40731-240743-541049-141237-241536-241737-242219-2)CM-2410 (40731-340743-641049-241237-341536-341737-342219-3)
- Item Number (Lot Number)
- Amount recalled
- 976 units
Where it was sold
- Nationwide
Why it was recalled
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
This product could cause temporary or reversible health problems — stop using it.
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