Device product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Z-2071-2013
Product summary
- Event
- Event 65800
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2071-2013
Official wording
Reason: The trial stems were manufactured using the wrong design.
Code information: Lots: B209033, B225119
Distribution pattern: US Distribution to the state of Tennessee only.
Derived failure modes
-
Unknown
The trial stems were manufactured using the wrong design.