FDA Recall
Terminated
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Recall: Z-2076-2013
·
Initiated July 16, 2013
Recall
- Recall Number
- Z-2076-2013
- Event Number
- 65800
- Firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany
- FEI Number
- 3002808472
- Product Code
- HWT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 16, 2013
- Posted
- August 26, 2013
- Terminated
- June 4, 2014
Description
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Reason
The trial stems were manufactured using the wrong design.
Action
The firm notified their consignees of their product recall by parcel post on 07/16/2013.
Distribution
US Distribution to the state of Tennessee only.
Quantity
6 units