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. The units were distributed only in Tennessee.
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 the source text does not explicitly state that no injuries or illnesses have been reported, nor does it confirm that the hazard is purely theoretical without risk of harm.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling five units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS. The specific product reference is 99-0155/12, with a stem size of S-0, proximal stem diameter of 12 mm, and length of 180 mm. The affected lots are B208037 and B225126.
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. Patients who have received these specific trial stems should contact their healthcare provider or Waldemar Link for further instructions regarding the recall.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 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 (2)
- Lots: B208037
- B225126
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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