FDA Device recall Z-2064-2013
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox by Waldemar Link And Kg Hq, citing the trial stems were manufactured using the wrong design.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2064-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-16 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Waldemar Link And Kg Hq |
| Distribution | TN |
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Reason
The trial stems were manufactured using the wrong design.
Identifiers
| code_info | Lots: B208033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2064-2013%22
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