Device product
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Z-0821-2017
Product summary
- Event
- Event 75892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51 units
- Official record key
device-enforcement:Z-0821-2017
Official wording
Reason: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Code information: A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229
Distribution pattern: Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Derived failure modes
-
Unknown
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.