Linkbio recalls all LINK SLED Knee System poly tibial components (7mm x 45mm) due to potential early loosening from improper surgical installation. Affected units may require revision surgery sooner than expected.
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 (7mm x 45mm) because they can loosen early if not installed correctly during surgery. This might lead to revision surgery sooner than planned.
The poly tibial component can loosen early if the implant is not positioned correctly or cemented properly during surgery. This may cause the implant to fail sooner than intended, requiring revision surgery.
Patients who received the LINK SLED Knee System with the specific poly tibial component (7mm x 45mm) during surgery are affected. Surgeons who installed the component without proper technique are at higher risk.
Check if your knee implant has the poly tibial component labeled as 7mm x 45mm. The item number is 15-2028/01, and all units were sold within the labeled expiration date.
Reach out to your surgeon to confirm if you received the recalled poly tibial component during surgery.
The recall is due to potential early loosening from improper surgical installation, which could lead to revision surgery sooner than expected.
No, the recall does not require stopping use; it involves checking with your surgeon about potential revision needs.
Check for the poly tibial component labeled 7mm x 45mm with item number 15-2028/01.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1511-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1511-2023 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.
