Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling nine trial stems for the MP 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 and involves a medical device defect (wrong design) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling nine units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, reference 99-0143/16. The specific units involved are Stem size 02, with a proximal stem diameter of 16 mm and a length of 250 mm. The recall covers lots B226103 and B051034.
The recall was initiated because the trial stems were manufactured using the wrong design. The agency has classified this recall as Class II.
The affected products were distributed in the United States to the state of Tennessee only. Consumers and healthcare providers should contact Waldemar Link for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 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 (2)
- Lots: B226103
- B051034
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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