Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five 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 is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported injuries or hospitalizations, as the probability of serious adverse health consequences is considered remote.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling five units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS. The specific product affected is Reference 99-0142/18, Stem size 003, with a proximal stem diameter of 18 mm and a length of 210 mm. The units are identified by Lot B208032.
The recall was initiated because the trial stems were manufactured using the wrong design. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed in the United States to the state of Tennessee only. Healthcare providers and patients who have received these specific trial stems should contact Waldemar Link for further instructions on removal or replacement.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Hazard
- Affected units
- 5
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 (1)
- Lots: B208032
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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