FDA Recall
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 ligament reconstruction.
Recall: Z-2422-2018
·
Initiated July 11, 2013
Recall
- Recall Number
- Z-2422-2018
- Event Number
- 80282
- Firm
- Cayenne Medical Inc.
- FEI Number
- 3006108336
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 11, 2013
- Terminated
- September 14, 2018
- Address
- 16597 N 92nd St, Ste 101, Scottsdale, AZ, 85260-1847
Description
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.
Reason
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Action
Customers were contacted on approximately 07/11/2013 and were instructed to return any affected products on hand.
Distribution
US nationwide distribution.
Quantity
976 units