Recall of Waldemar Link L-Shaped Femoral Augments with missing thread in preassembled screw. Affected items include specific sizes and models sold up to March 2025. Consumers should check item numbers and serial codes.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Waldemar Link is recalling L-Shaped Femoral Augments that were delivered with a preassembled screw missing its thread. This defect could cause improper fixation during surgery, potentially leading to complications for patients. The recall affects specific sizes and models sold up to March 2025.
The preassembled screw in the device is missing its thread, which could lead to improper fixation during surgery. This defect might cause the implant to become loose or fail to stay in place, potentially causing complications for the patient.
Patients who received the recalled L-Shaped Femoral Augments during surgery are most at risk. The recall applies to specific sizes and models manufactured up to March 2025.
Check the item number on the device, which includes size and cement type (e.g., 880-320/12 for size 0 - cemented small). The recall covers specific models manufactured up to March 2025.
Look for the item number on the device, which includes size and cement type (e.g., 880-320/12 for size 0 - cemented small).
The device was delivered with a preassembled screw that was missing its thread, which could lead to improper fixation during surgery.
The recall includes specific sizes and models: 880-320/12 (size 0 - cemented small), 880-320/22 (size 0 - cemented large), and other variants up to size 9-10 - cemented large.
The affected products were 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-1701-2025 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-1701-2025 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.