Linkbio recalls its ENDO MODEL SLED TIBIAL COMP 8mm x 55mm knee implant due to potential early loosening from improper placement. Affected units have specific item numbers and expiration dates. Contact Linkbio for details.
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 SLED TIBIAL COMP 8mm x 55mm knee implant because improper surgical placement or cementing could cause early loosening, requiring revision surgery. This affects patients who had the implant placed between specific dates and with certain item numbers.
The implant may loosen prematurely if not positioned correctly during surgery or if cementing technique is inadequate. This can lead to the need for earlier revision surgery than expected, which is a more complex procedure.
Patients who received the Linkbio ENDO MODEL SLED TIBIAL COMP 8mm x 55mm knee implant with item number 15-2030/15 between the labeled expiration dates are affected. Surgeons who used this implant during the specified time frame are most at risk.
Check for the item number 15-2030/15 on the implant packaging or label. The recall covers all units within the labeled expiration date as of the time of sale.
Look for the item number 15-2030/15 on the implant packaging or label to confirm if it is affected.
The recall is due to potential early loosening from improper surgical placement or inadequate cementing technique, which could require revision surgery earlier than expected.
Yes, check the item number on your implant packaging or label. If it matches 15-2030/15, contact Linkbio for further instructions.
The recall addresses the risk of needing revision surgery, not direct injury. The hazard is related to surgical outcomes, not immediate harm.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1538-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1538-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
