Recall Z-2063-2013 ยท HWT Template
Waldemar Link GmbH & Co. KG (Corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
| Date | Aug 26, 2013 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | The trial stems were manufactured using the wrong design. |
| Root cause | Device Design |
| Action | The firm notified their consignees of their product recall by parcel post on 07/16/2013. |
| Quantity | 5 units |
| Distribution | US Distribution to the state of Tennessee only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955296 | LINK MP RECONSTRUCTION HIP Link America, Inc., Feb 14, 1996 |