Recall of Waldemar Link Tibial Augment devices with missing thread in preassembled Femoral Augment screw. Affected items include specific sizes and models sold up to March 2025.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Waldemar Link is recalling Tibial Augment devices that came with a preassembled Femoral Augment screw missing its thread. This defect could cause improper fitting during surgery, potentially leading to complications.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread. This defect could cause improper fitting during surgery, potentially leading to complications like improper joint alignment or instability.
Patients who received the recalled Tibial Augment devices during surgery. Surgeons and medical staff using these devices for orthopedic procedures are most at risk.
Check for item numbers 880-331/11 through 880-339/23 on the device packaging or label. These items were manufactured up to March 1, 2025, and sold as part of the LINK SymphoKnee Femoral Augments.
Look for item numbers 880-331/11 through 880-339/23 on the device packaging or label.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread, which could cause improper fitting during surgery.
Check the device label for item numbers 880-331/11 through 880-339/23. If you have the recalled item, contact Waldemar Link for further instructions.
The recall applies to devices 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-1702-2025 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1702-2025 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.