CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
Trial Stem for MP(R) Reconstruction Prothesis recalled
Waldemar Link GmbH & Co. KG (Corp. Hq.) is recalling Trial Stem for MP(R) Reconstruction Prothesis, distributed in Tennessee. The recall was initiated on 16 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2060-2013
- FDA event ID
- 65800
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.), Hamburg
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2013
- FDA classified
- 27 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2013 | Recall initiated by company | |
| 27 Aug 2013 | Classified by FDA | +42 days |
| 4 Sep 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The trial stems were manufactured using the wrong design.
Product as listed by the FDA
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Where it was distributed
US Distribution to the state of Tennessee only.
Questions about this recall
Is Trial Stem for MP(R) Reconstruction Prothesis recalled?
Yes. Waldemar Link GmbH & Co. KG (Corp. Hq.) recalled Trial Stem for MP(R) Reconstruction Prothesis on 16 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2060-2013.
Why was it recalled?
The trial stems were manufactured using the wrong design.
Which lots are affected?
Lots: B208030, B225121
Where was it sold?
US Distribution to the state of Tennessee only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Waldemar Link GmbH & Co. KG (Corp. Hq.)
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LINK Universal Handle, with quick coupling, Stainless Steel recalled | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Foreign Material | Nationwide |
| Device | CLASS II | Trial Stem for MP(R) Reconstruction Prothesis recalled | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Other | TN |
| Device | CLASS II | Trial Stem for MP(R) Reconstruction Prothesis recalled | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Other | TN |
| Device | CLASS II | Trial Stem for MP(R) Reconstruction Prothesis recalled | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Other | TN |
| Device | CLASS II | Trial Stem for MP(R) Reconstruction Prothesis recalled | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Other | TN |
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