Z-0821-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- December 7, 2016
- Termination Date
- July 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Code Information
A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229