Linkbio recalls all LINK SLED Knee System poly tibial components (13x58mm) due to potential early loosening from improper surgical placement. Affected patients should consult their surgeon for possible revision.
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 (13x58mm) because they may loosen too soon if not properly fitted during surgery. This could lead to earlier revision surgery than expected.
The poly tibial component may loosen earlier than expected if the implant is not positioned correctly during surgery or if cementing technique is inadequate. This could require revision surgery sooner than planned.
Patients who received the LINK SLED Knee System with the specific poly tibial component (13x58mm) are affected. Those who had the implant placed with improper technique or inadequate cementing are at higher risk.
Check if your LINK SLED Knee System has a poly tibial component measuring 13x58mm. The item number is 15-2028/16. All lot numbers within the labeled expiration date are affected.
Verify if your LINK SLED Knee System has the poly tibial component size 13x58mm with item number 15-2028/16.
No, the recall does not require stopping use. Patients should consult their surgeon about potential revision if they had improper surgical placement.
Contact your surgeon to discuss whether revision surgery may be needed due to potential early loosening from improper fitting.
The recall includes updated surgical training and technique guidance, but no physical fix is provided for existing implants.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1526-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1526-2023 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.
