Linkbio recalls all LINK SLED Knee System poly tibial components (13mm x 50mm) with item number 15-2028/08 due to potential early loosening from improper surgical technique. 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 all LINK SLED Knee System poly tibial components (13mm x 50mm) with item number 15-2028/08 because poor surgical placement or cementing could cause the implant to loosen early, requiring revision surgery. This affects patients who received this specific knee implant component during surgery.
The implant can loosen prematurely if not positioned correctly during surgery or if cementing technique is inadequate. This may lead to the need for earlier revision surgery than expected, but does not cause immediate injury or death.
Patients who received the LINK SLED Knee System poly tibial component (13mm x 50mm) with item number 15-2028/08 during surgery are affected. Those who had the implant placed with improper positioning or inadequate cementing are at higher risk for early revision.
Check if your knee implant has the poly tibial component labeled 13mm x 50mm with item number 15-2028/08. The recall covers all units within the labeled expiration date.
Reach out to Linkbio directly for guidance on whether your implant is affected and next steps.
The recall is for potential early implant loosening due to surgical technique, which may require revision surgery but does not cause immediate injury or death.
No, the recall does not require stopping use. Patients should contact Linkbio for guidance on whether their implant is affected.
Check if your knee implant has the poly tibial component labeled 13mm x 50mm with item number 15-2028/08.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1518-2023 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.
