Linkbio recalls its ENDO model knee implant due to potential early loosening from improper surgical technique, requiring revision surgery. 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 its ENDO model knee implant (SLED TIBIAL COMP 13 MM X 55 MM) because poor surgical placement or cementing could cause early loosening, leading to revision surgery. This affects patients who had the implant placed using outdated techniques.
The implant can loosen prematurely if not positioned correctly during surgery or if cementing is inadequate. This may require earlier revision surgery than expected, which carries risks of complications.
Patients who received the Linkbio ENDO model knee implant with item number 15-2030/12 are most at risk. The recall targets those who had the implant placed using older techniques that may cause early loosening.
Check for the item number 15-2030/12 on the implant packaging or label. The recall covers all units within the labeled expiration date.
Look for the item number 15-2030/12 on the implant packaging or label.
The recall is due to potential early loosening from improper surgical technique or inadequate cementing, which could lead to revision surgery.
No, the recall does not require stopping use. Patients should contact their surgeon for guidance on whether revision surgery is needed.
Check for the item number 15-2030/12 on the implant packaging or label. The recall covers all units within the labeled expiration date.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1535-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1535-2023 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.
