Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
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 involves a medical device with a manufacturing defect (wrong design) and is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling five units of the TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, reference 99-0142/20. The specific units involved are Stem size 004, with a proximal stem diameter of 20 mm and a length of 210 mm. The recall number is Z-2064-2013.
The recall was initiated because the trial stems were manufactured using the wrong design. The affected units are identified by Lot B208033. These products were distributed in the United States to the state of Tennessee only.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any injuries or illnesses associated with the use of these devices.
The recalled product
- Product
- TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 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: B208033
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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