Linkbio recalls medium-sized ENDOSLED knee implants due to potential early loosening from improper surgical technique. Affected items 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 medium-sized ENDOSLED knee implants because poor surgical placement or cementing could cause early loosening. This might require revision surgery sooner than expected.
The implant may loosen prematurely if not positioned correctly during surgery or if cementing is insufficient. This could lead to the need for revision surgery earlier than planned.
Patients who received the ENDOSLED knee implant with item number 15-2020/52 are affected. Those who had the implant placed with improper technique or inadequate cementing are at higher risk.
Check for the item number 15-2020/52 on the implant packaging. The recall covers all units within the labeled expiration date.
Look for the item number 15-2020/52 on the implant packaging or label.
The recall is due to potential early loosening from improper surgical placement or inadequate cementing, which could require revision surgery sooner than expected.
Check the implant packaging for item number 15-2020/52. If you have this item, contact Linkbio for guidance.
The recall does not provide a fix; it requires review of surgical technique and possible revision surgery if issues arise.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1509-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1509-2023 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.