Linkbio recalls medium-sized POREX ENDO SLED KNEE FEM COMP implants for potential early loosening from improper surgical placement. Affected units sold with item number 15-222:52.
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 POREX ENDO SLED KNEE FEM COMP implants because they may loosen early if not positioned correctly during surgery. This could lead to needing revision surgery sooner than expected.
The implant may loosen earlier than expected if not positioned correctly during surgery or if cementing technique is inadequate. This could require revision surgery sooner than planned.
Patients who received this specific knee implant during surgery are likely affected. Surgeons who used the implant without proper technique face the highest risk of complications.
Check for the item number 15-2220/52 on the implant packaging. The product was sold with expiration dates within the lot numbers.
Look for item number 15-2220/52 on the implant packaging or documentation.
The recall is due to potential early loosening from improper surgical positioning or inadequate cementing technique, which could lead to revision surgery.
No action is required for the implant itself; the recall is for surgical teams to review technique.
Check for item number 15-2220/52 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-1541-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1541-2023 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.
