Linkbio recalls ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM knee implants due to potential early failure from improper surgical 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 a specific knee implant model because it can fail earlier than expected if not installed correctly during surgery. This could require additional surgery or revision sooner than planned.
The implant may loosen or wear faster if not positioned correctly or cemented properly during surgery. This can lead to the need for earlier revision surgery than intended.
Patients who received this specific knee implant during surgery are affected. Surgeons who used the implant without proper technique are at higher risk.
Check for the item number 15-2030/02 on the implant packaging. The product was sold with a labeled expiration date.
Look for the item number 15-2030/02 on the implant packaging or documentation.
The recall is due to potential early failure from improper surgical installation, which could require revision surgery sooner than expected.
If you received this specific implant model, check the item number on your packaging. No action is needed if you were not the surgeon who installed it.
This is a medical recall related to surgical technique, not a direct safety hazard for the consumer. The risk is specific to improper installation during surgery.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1527-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1527-2023 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.
