Waldemar Link GmbH & Co. KG is recalling 3 units of the LINK MP Reconstruction System Neck Segment (Item Number 99-0984/32), a component used in revision hip replacement surgeries. The recall was initiated because the main label and the patient label incorrectly identify the component as size XXL when it is actually a standard-sized neck segment. While the listed measurements for length, angle, and offset are correct, the incorrect size designation could lead to the selection of the wrong part during surgery.
The labeling error may cause a surgeon to believe they are implanting an XXL neck segment when they are actually using a standard size. This mismatch could result in improper fitting of the hip implant or surgical delays while the correct component is located.
Intended for revision hip arthroplasty in patients with poor bone stock.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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