Linkbio recalls LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM (Item 15-2230/10) due to potential early loosening from improper implant positioning or cementing. Affected patients should contact Linkbio for guidance.
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 loosen early if not positioned or cemented correctly during surgery. This could lead to surgery needing to be repeated sooner than expected.
The implant may loosen earlier than expected if not properly positioned during surgery or if cementing technique is inadequate. This could require additional surgery to fix the issue.
Patients who received this specific knee implant model during surgery are affected. Those who had the implant positioned or cemented incorrectly are at higher risk.
Check for the model name 'SLED TIBIAL COMP 9 MM X 55 MM' and item number 15-2230/10 on the implant packaging or surgical records. The recall covers all units within the labeled expiration date.
Patients should contact Linkbio directly to discuss their specific implant and whether they need additional steps.
The recall is due to potential early loosening from improper implant positioning or inadequate cementing during surgery, which could lead to needing additional surgery.
No, the implant is a surgical device. Patients should contact Linkbio for guidance on whether they need additional steps.
Look for the model name 'SLED TIBIAL COMP 9 MM X 55 MM' and item number 15-2230/10 on the implant packaging or surgical records.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1549-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1549-2023 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.
