Linkbio recalls all LINK SLED Knee System poly tibial components (7mm x 50mm) due to potential early joint failure from improper implant positioning during surgery. Affected units 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 (7mm x 50mm) because they can cause early joint failure if not properly positioned during surgery. This could lead to revision surgery sooner than expected.
The poly tibial component can loosen or wear faster if the implant isn't positioned correctly or cemented properly during surgery. This may cause joint failure earlier than intended, requiring revision surgery.
Patients who received the LINK SLED Knee System with the specific poly tibial component (7mm x 50mm) during surgery are affected. Surgeons who used the product without proper technique are at higher risk.
Check for the poly tibial component labeled 7mm x 50mm with item number 15-2028/05. The product was sold with expiration dates within the labeled timeframe.
Reach out to your surgeon to confirm if you received the recalled poly tibial component during surgery.
No, the recall does not require immediate discontinuation. Patients should contact their surgeon to check if they received the affected component.
The component can loosen or wear faster if not positioned correctly during surgery, potentially requiring revision surgery sooner than expected.
Check for the poly tibial component labeled 7mm x 50mm with item number 15-2028/05. The product was sold with expiration dates within the labeled timeframe.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1515-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1515-2023 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.
