Recall Z-2422-2018 ยท HWC Screw, Fixation, Bone
Cayenne Medical Inc.
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.
| Date | Jul 11, 2013 |
| Status | Terminated |
| Reason | Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. |
| Root cause | Device Design |
| Action | Customers were contacted on approximately 07/11/2013 and were instructed to return any affected products on hand. |
| Quantity | 976 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083612 | APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM Cayenne Medical, Inc., Mar 4, 2009 |