Waldemar Link recalls Posterior Femoral Augment implants with missing thread screws. These devices may not function properly during surgery. Affected items have specific item numbers and sizes.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Waldemar Link is recalling certain Posterior Femoral Augment implants because they were delivered with a preassembled screw that lacks its thread. This defect could cause the implant to fail during surgery, potentially leading to complications for patients.
The implant screws were delivered without their threads, meaning they cannot securely attach to the bone. This defect could cause the implant to loosen or fail during surgery, potentially requiring additional procedures or causing complications.
Patients who received the recalled Posterior Femoral Augment implants (item numbers 880-310/11 to 880-319/22) manufactured up to March 1, 2025, are affected. Surgeons and medical facilities using these implants are at risk of complications during procedures.
Check the item number on the implant packaging or label. The affected models have specific sizes (0-10) and cemented versions (small, medium, large, extra-large). The recall covers all units manufactured up to March 1, 2025.
Reach out to Waldemar Link directly to confirm if your implant is affected and get instructions for next steps.
The implants were delivered with a preassembled screw that is missing its thread, which could cause the implant to fail during surgery.
All Posterior Femoral Augment implants with item numbers 880-310/11 to 880-319/22, manufactured up to March 1, 2025.
The recall does not require immediate discontinuation; contact Waldemar Link to determine if your implant is affected and follow their guidance.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-1700-2025 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1700-2025 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.