Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a manufacturing defect (wrong design) where no specific injuries or illnesses are reported in the source text, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling four units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, reference 99-0143/22. The affected units are stem size 05, with a proximal stem diameter of 22.5 mm and a length of 250 mm. The specific lots involved are B209034 and B225123.
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 only to the state of Tennessee. No specific hospitals or patients are named in the source text. Healthcare providers and patients who may have received these specific trial stems should contact the manufacturer or their regulatory authority for further instructions.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 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: B209034
- B225123
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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