Linkbio recalls all LINK SLED Knee System poly tibial components (13mm x 45mm) due to potential early joint failure from improper implant positioning during surgery.
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 45mm) because poor surgical technique can cause the implant to loosen or wear faster than expected, leading to earlier joint revision surgery.
The implant can loosen or wear faster if not positioned correctly during surgery or if cementing technique is inadequate. This may cause the joint to fail earlier than expected, requiring revision surgery.
Patients who received the LINK SLED Knee System with the specific poly tibial component (13mm x 45mm) during surgery. Those who had the implant placed with improper positioning or inadequate cementing are at higher risk.
Check for the poly tibial component labeled 13mm x 45mm with item number 15-2028/04. The recall covers all units within the labeled expiration date.
Your surgeon can confirm if your implant is part of this recall based on surgical details.
No, this recall does not require stopping use. The issue is related to surgical technique, not normal use.
Contact your surgeon to determine if your implant is part of the recall and whether revision surgery is needed.
The recall includes updated surgical training and techniques to prevent the issue, but no product fix is provided.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1514-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1514-2023 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.
