Linkbio recalls ENDO model knee implants due to early loosening from improper installation. Affected units have specific item numbers and expiration dates.
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 their ENDO model knee implants because they can become loose too soon if not installed correctly. This might require surgery earlier than expected.
The implants can loosen early if not positioned correctly or cemented properly during surgery. This may lead to needing extra surgery sooner than planned.
Patients who received the ENDO model knee implants with item number 15-2030/14 are affected. Those who had the implants installed with improper technique are at higher risk.
Check for the item number 15-2030/14 on the implant packaging or label. The product was sold with a specific expiration date and lot numbers within that date.
Look for the item number 15-2030/14 on the implant packaging or label.
The recall is due to early loosening risks from improper installation, which could lead to needing extra surgery sooner than expected.
If you have the specific item number 15-2030/14, check with your surgeon about proper installation technique.
The recall does not provide a fix; it focuses on checking installation technique and potential need for revision surgery.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1537-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1537-2023 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.
