Waldemar Link recalls LinkSymphoKnee Distal Femoral Augment Size 7-8 for potential wrong screw insertion during knee replacement surgery.
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Waldemar Link is recalling a specific knee implant size for possible incorrect screw placement during surgery. This could lead to improper joint function or complications after surgery.
The fixation screw may be inserted through the wrong side of the implant (distal to proximal instead of proximal to distal). This incorrect orientation could cause improper joint alignment or failure of the implant.
Patients who received this specific knee implant size during primary or revision total knee replacement surgery. Surgeons and medical staff using this implant are most at risk.
Check for product code 880-307/11, UDI-DI 04026575257379, and lot number 2123225 on the implant packaging. This implant is intended for primary and revision total knee replacements in mature patients.
Look for product code 880-307/11, UDI-DI 04026575257379, and lot number 2123225 on the implant packaging.
The recall does not specify if the implant is safe; it indicates a potential risk of incorrect screw insertion during surgery.
The recall does not provide specific action steps for affected patients.
Check for product code 880-307/11, UDI-DI 04026575257379, and lot number 2123225 on the implant packaging.
We’ve drafted a message you can send Waldem:Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2066-2023 — Waldem:Link Waldem:Link Hello, I own a Waldem:Link that is covered by recall Z-2066-2023 from Waldem: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.