Linkbio recalls ENDO model knee implants due to potential early loosening from improper placement or cementing, risking revision surgery.
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Linkbio is recalling its ENDO model knee implants because they can loosen early if not positioned correctly or cemented properly, which might require surgery sooner than expected.
The implants can loosen early if not positioned correctly during surgery or if cementing is inadequate. This might lead to needing revision surgery earlier than planned.
Patients who received the ENDO model knee implants with item number 15-2030/13 are affected. Those who had the implant placed without proper technique are at higher risk.
Check for the item number 15-2030/13 on the implant packaging or label. The product was sold with a specific expiration date as labeled.
Look for the item number 15-2030/13 on the implant packaging or label to confirm if it's recalled.
The recall is due to potential early loosening from improper positioning or cementing during surgery, which could lead to revision surgery.
The official notice does not mention a fix; it focuses on the recall and potential need for revision surgery.
Check for the item number 15-2030/13 on the implant packaging or label.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1536-2023 from Linkbio. 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.
