Linkbio recalls all LINK SLED Knee System poly tibial components (11x58mm) due to potential early loosening from improper surgical installation. 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 (11x58mm) because they may loosen too soon if not installed correctly during surgery. This could lead to needing surgery earlier than expected.
The poly tibial component may loosen earlier than expected if the implant is not positioned correctly or cemented properly during surgery. This could cause the need for revision surgery sooner than planned.
Patients who received the LINK SLED Knee System with the specific poly tibial component (11x58mm) during surgery. Those who had the implant installed with improper technique are at higher risk.
Check if your knee implant has the model number 15-2028/15 and the size 11x58mm. The recall covers all units within the labeled expiration date.
Contact your surgeon to determine if your implant is affected and whether revision surgery may be needed.
No, only the specific poly tibial component (11x58mm) with item number 15-2028/15.
The recall does not require replacement; your surgeon will advise if revision surgery is needed.
Check for the model number 15-2028/15 and size 11x58mm on your implant. The recall covers all units within the labeled expiration date.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1525-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1525-2023 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.
