Device product
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 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-0824-2017
Product summary
- Event
- Event 75892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0824-2017
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: B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876
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.