Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 and involves a medical device with a design defect. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling nine units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, reference 99-0155/22. The specific units affected are Stem size S-5, with a proximal stem diameter of 22.5 mm and a length of 180 mm. The affected lots are B225115, B048089, and B102030.
The recall was initiated because the trial stems were manufactured using the wrong design. The agency classification for this recall is Class II.
The affected units were distributed in the United States only to the state of Tennessee. Consumers and healthcare providers who have these specific trial stems should contact the recalling firm for further instructions.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
- Manufacturer
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Hazard
- Affected units
- 9
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 (3)
- Lots: B225115
- B048089
- B102030
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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