Linkbio recalls all LINK SLED Knee System poly tibial components (11mm x 50mm) due to potential early loosening from improper implant positioning or cementing technique.
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 (11mm x 50mm) because improper surgical placement or cementing could cause the implant to loosen early, requiring revision surgery. This affects patients who had this specific knee implant component installed.
The implant may loosen earlier than expected if not positioned correctly during surgery or if cementing technique is inadequate. This could lead to the need for revision surgery sooner than planned.
Patients who received the LINK SLED Knee System poly tibial component (11mm x 50mm) with item number 15-2028/07 are most at risk. The recall applies to those who had this specific implant component installed during surgery.
Check if your knee implant has the poly tibial component labeled 11mm x 50mm with item number 15-2028/07. The recall covers all units within the labeled expiration date.
Verify your knee implant's size (11mm x 50mm) and item number (15-2028/07) to confirm if it's affected.
The recall does not require stopping use; it's a review of surgical technique to prevent early failure.
Check your implant details against the recall criteria. If affected, contact Linkbio for guidance on next steps.
The recall addresses potential early loosening from improper placement, but it's not an immediate risk for most users.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1517-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1517-2023 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.
