Z-2076-2013 Class II Terminated
FDA device recall Z-2076-2013 was initiated by Waldemar Link GmbH & Co. KG (Corp. Hq.) on July 16, 2013 and is designated Class II. Reason for recall: The trial stems were manufactured using the wrong design. The recall status is terminated (terminated June 4, 2014). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2013
- Initiation Date
- July 16, 2013
- Termination Date
- June 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product 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 for Recall
The trial stems were manufactured using the wrong design.
Distribution Pattern
US Distribution to the state of Tennessee only.
Code Information
Lots: B225116, B128075