Linkbio recalls LINK SLED Knee System (item 15-2020/60) due to potential early implant failure 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 its LINK SLED Knee System (item number 15-2020/60) because improper surgical placement or cementing could cause the implant to loosen early, requiring revision surgery. This affects patients who had the knee system implanted using this specific model.
The implant can loosen earlier than expected if the surgeon does not position it correctly or uses insufficient cement. This may require revision surgery sooner than intended, but does not cause immediate harm during normal use.
Patients who received the LINK SLED Knee System (item number 15-2020/60) during surgery are affected. Those who had the implant placed with improper positioning or inadequate cementing are at higher risk.
Check for the item number 15-2020/60 on the packaging or surgical records. 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.
No, only the LINK SLED Knee System with item number 15-2020/60 is affected.
The recall is due to potential early implant failure from improper surgical technique, which could lead to revision surgery.
No, the recall does not require stopping use; patients should contact Linkbio for specific guidance.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1510-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1510-2023 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.
