Waldemar Link recalls certain LINK STEM prosthesis models due to potential incorrect neck fit causing improper joint alignment. Affected units have specific lot numbers and sizes.
The reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod.
Waldemar Link is recalling specific LINK STEM prosthesis models that may not fit properly in the hip joint. This could lead to improper alignment and complications if the prosthesis isn't correctly positioned.
The prosthesis may not screw in deeply enough, causing the neck to be positioned incorrectly. This could lead to improper joint alignment and potential complications if the prosthesis doesn't fit properly.
Patients who have received the recalled LINK STEM prosthesis (size XS-0, 12mm diameter, 160mm length) with specific lot numbers are affected. Those with hip joint reconstruction procedures are most at risk.
Check for the product name 'LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS' with size XS-0 (12mm diameter, 160mm length). Affected units have specific lot numbers listed in the recall.
Verify the product size (XS-0, 12mm diameter, 160mm length) and lot numbers from the recall list.
The recall is due to a potential issue with the reaming guide not screwing in completely, which could lead to improper neck positioning and joint alignment.
Affected lot numbers include 1435077, 1515029, 1718103, 150401/0217, 1734168, 1726056.
The recall does not require immediate discontinuation; however, you should check if your prosthesis matches the affected specifications.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-0733-2019 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-0733-2019 from Waldemar Link. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
