Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 8 units of trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a design defect without reported harm.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 8 units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, reference 99-0155/20. The affected units are Stem size S-4, with a proximal stem diameter of 20 mm and a length of 180 mm. The recall is limited to lots B225118 and B101171.
The recall was initiated because the trial stems were manufactured using the wrong design. The product was distributed in the United States only to the state of Tennessee.
Healthcare providers and patients who have received or used these specific trial stems should contact Waldemar Link for further instructions on the recall.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: B225118
- B101171
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Waldemar Link GmbH & Co. KG (Corp. Hq.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
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