Linkbio recalls all LINK SLED Knee System poly tibial components (7mm x 55mm) due to potential early loosening from improper surgical placement. Affected patients should consult their surgeon for evaluation.
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 (7mm x 55mm) because they may loosen too soon if not properly fitted during surgery. This could lead to needing extra surgery sooner than expected.
The poly tibial component may loosen earlier than expected if the implant isn't positioned correctly or cemented properly during surgery. This could cause the need for additional surgery to fix the problem.
Patients who received the LINK SLED Knee System with the specific poly tibial component (7mm x 55mm) during surgery. Those who had the implant fitted with improper positioning or cementing technique are at higher risk.
Check if your LINK SLED Knee System has a poly tibial component measuring 7mm x 55mm. The item number is 15-2028/09, and all lot numbers are affected.
Contact your surgeon to determine if you have the recalled poly tibial component and whether revision surgery might be needed.
The recall does not require immediate discontinuation. Patients should consult their surgeon to assess if revision surgery is needed.
The poly tibial component may loosen earlier than expected if not positioned correctly or cemented properly during surgery.
Check if your LINK SLED Knee System has a poly tibial component measuring 7mm x 55mm with item number 15-2028/09.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1519-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1519-2023 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.
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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.
