Linkbio recalls all LINK SLED Knee System poly tibial components (9x58mm) due to potential early loosening from improper surgical technique. Affected items 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 all LINK SLED Knee System poly tibial components (9x58mm) because they might loosen too soon if not installed correctly during surgery. This could lead to needing extra surgery sooner than expected.
The implant might loosen early if not positioned correctly or cemented properly during surgery. This could cause the knee replacement to fail sooner than intended, requiring additional surgery.
Patients who received the LINK SLED Knee System poly tibial component (9x58mm) with item number 15-2028/14. Surgeons who used this component during procedures are most at risk of needing revision surgery.
Check for the poly tibial component (9x58mm) with item number 15-2028/14. The product has a specific expiration date and UDI-DI code 04026575359462.
Identify the item number (15-2028/14) and expiration date on the component.
The recall is due to potential early loosening of the implant if not installed correctly during surgery, which could lead to needing revision surgery sooner than expected.
No, the recall does not require stopping use. The issue is related to surgical technique, not normal use.
Check for the poly tibial component (9x58mm) with item number 15-2028/14 and 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-1524-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1524-2023 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.
