Linkbio recalls POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM knee implants due to potential early loosening from improper surgical technique. 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 become loose or wear out too quickly if not properly positioned during surgery. This could lead to needing surgery sooner than expected.
The implant may loosen or wear out faster than expected if not positioned correctly or cemented properly during surgery. This could cause the need for additional surgery earlier than planned.
Patients who received this specific knee implant model during surgery are affected. Surgeons who used improper techniques during implant placement are at higher risk.
Check for the item number 15-2230/03 on the implant packaging. The product was sold with a specific expiration date and lot numbers within that date range.
Look for the item number 15-2230/03 on the implant packaging or documentation.
The recall is due to potential early loosening or increased wear of the implant if not positioned correctly or cemented properly during surgery.
The official notice does not specify replacement requirements; affected patients should consult their surgeon about next steps.
Check for the item number 15-2230/03 on the implant packaging or documentation.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1544-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1544-2023 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.
