Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses 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 involves a medical device with a design defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling five units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS. The specific units affected are identified by reference number 99-0143/20, stem size 04, proximal stem diameter of 20 mm, and length of 250 mm. The lots involved are B209033 and B225119.
The recall was initiated because the trial stems were manufactured using the wrong design. These products were distributed in the United States only to the state of Tennessee.
Healthcare providers and patients who may have these specific trial stems in inventory or implanted should contact Waldemar Link for further instructions on the recall.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 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: B209033
- B225119
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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