Z-2422-2018 Class II Terminated
FDA device recall Z-2422-2018 was initiated by Cayenne Medical Inc. on July 11, 2013 and is designated Class II. Reason for recall: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. The recall status is terminated (terminated September 14, 2018). Affected quantity: 976 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- July 11, 2013
- Termination Date
- September 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 976 units
Product 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 for Recall
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Distribution Pattern
US nationwide distribution.
Code Information
Item Number (Lot Number): CM-2409 (40731-2, 40743-5, 41049-1, 41237-2, 41536-2, 41737-2, 42219-2), CM-2410 (40731-3, 40743-6, 41049-2, 41237-3, 41536-3, 41737-3, 42219-3).