Waldemar Link recalls Distal Femoral Augment implants with missing thread screws. These implants (item numbers 880-300/11 to 880-309/22) were manufactured up to March 2025. The missing thread could cause improper fixation during surgery.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Waldemar Link is recalling certain Distal Femoral Augment implants because they were shipped with a preassembled screw that lacks its thread. This defect could lead to improper fixation during surgery, potentially causing complications for patients who have received the implant.
The implants were delivered with a preassembled screw that is missing its thread. This defect could cause the screw to not properly anchor to the bone during surgery, potentially leading to implant failure or complications after the procedure.
Patients who received the recalled Distal Femoral Augment implants (item numbers 880-300/11 to 880-309/22) manufactured up to March 2025 are affected. Surgeons and medical facilities that used these implants during procedures are at the highest risk.
Check the item number on the implant packaging or label. The recalled items have specific model numbers: 880-300/11 (size 0, cemented small), 880-300/21 (size 0, cemented large), and other sizes up to 880-309/22 (size 9-10, cemented extra large). These implants were manufactured up to March 1, 2025.
Look for the item number on the implant packaging or label to confirm if it's in the recalled list (880-300/11 to 880-309/22).
Inform your surgeon about the recall and whether you received a recalled implant.
The implants were delivered with a preassembled screw that is missing its thread.
Item numbers 880-300/11 (size 0, cemented small), 880-300/21 (size 0, cemented large), and other sizes up to 880-309/22 (size 9-10, cemented extra large).
Manufactured up to March 1, 2025.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1699-2025 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1699-2025 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.
