Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a 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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing design error without specified immediate harm, fitting the criteria for a moderate severity score.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling four units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, reference 99-0142/12. The affected units are stem size 00, with a proximal stem diameter of 12 mm and a length of 210 mm. The specific lots involved are B208030 and B225121.
The recall was initiated because the trial stems were manufactured using the wrong design. The source text does not specify the nature of the design error or any associated clinical risks.
The affected units were distributed in the United States to the state of Tennessee only. The source text does not provide instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- 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
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Hazard
- Affected units
- 4
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: B208030
- B225121
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.
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