Linkbio recalls all LINK SLED Knee Systems with specific poly tibial components (11mm x 45mm) due to potential early loosening from improper implant positioning during surgery, requiring possible revision 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 Systems with the 11mm x 45mm poly tibial component (item number 15-2028/03) because improper surgical placement or cementing could cause the implant to loosen early, leading to revision surgery. This affects patients who had this specific knee implant installed.
The knee implant can loosen earlier than expected if not positioned correctly during surgery or if cementing technique is inadequate. This may require revision surgery sooner than intended, which carries risks of complications and additional recovery time.
Patients who received the LINK SLED Knee System with the 11mm x 45mm poly tibial component (item number 15-2028/03) during surgery are affected. Those who had the implant placed with suboptimal positioning or inadequate cementing are at higher risk for needing revision surgery.
Check if your knee implant has the 11mm x 45mm poly tibial component labeled as item number 15-2028/03. The recall covers all units within the labeled expiration date.
Reach out to your surgeon to discuss whether your implant matches the recalled model and if revision surgery might be needed.
The recall does not require stopping use; it focuses on potential revision surgery if the implant loosens early. Consult your surgeon for personalized advice.
Contact your surgeon to determine if your implant matches the recalled model and if revision surgery might be necessary.
No, only the specific LINK SLED Knee System with the 11mm x 45mm poly tibial component (item number 15-2028/03) is affected.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1513-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1513-2023 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.
