Recall of LinkSymphoKnee Distal Femoral Augment (Size 7-8) due to risk of improper screw insertion causing potential complications. Affected units include specific product codes and lot numbers.
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 certain LinkSymphoKnee Distal Femoral Augments (Size 7-8) because the fixation screw may be inserted through the wrong side of the augment. This could lead to improper alignment and potential complications after surgery.
The fixation screw is inserted through the wrong side of the augment (distal to proximal instead of proximal to distal). This incorrect orientation could cause improper alignment of the knee joint, potentially leading to complications after surgery.
Patients who have received the recalled LinkSymphoKnee Distal Femoral Augment (Size 7-8) for knee replacement surgery are affected. Surgeons and medical staff who used this specific product during procedures are at higher risk.
Check for the product code 880-307/21 and lot number 2123233 on the packaging. The augment is intended for primary and revision total knee replacements in skeletally mature patients.
Verify the product code 880-307/21 and lot number 2123233 on the packaging to confirm if the item is recalled.
The recall indicates a potential risk of improper screw insertion, so affected units should be checked and handled according to the recall instructions.
Check the product code and lot number on the packaging to see if it is recalled. If it matches, contact Waldemar Link for further instructions.
The recall applies to patients who have received the specific augment for knee replacement surgery. If you have the recalled product, contact your surgeon for guidance.
We’ve drafted a message you can send Waldem:Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2067-2023 — Waldem:Link Waldem:Link Hello, I own a Waldem:Link that is covered by recall Z-2067-2023 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.
