TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALD
FDA device recall Z-2080-2013 · posted 2013-08-26 · Terminated
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Reason for recall
- The trial stems were manufactured using the wrong design.
- Action taken
- The firm notified their consignees of their product recall by parcel post on 07/16/2013.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWT
- Quantity affected
- 8 units
- Distribution
- US Distribution to the state of Tennessee only.
- Date initiated
- 2013-07-16
- Date posted
- 2013-08-26
- Date terminated
- 2014-06-04
- Location
- Hamburg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINK MP RECONSTRUCTION HIP (K955296) | Link America, Inc. | 1996-02-14 |