Linkbio recalls all LINK SLED Knee System poly tibial components (13mm x 55mm, item 15-2028/12) due to potential early loosening from improper surgical technique. Affected patients should consult their surgeon.
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 55mm, item number 15-2028/12) because improper surgical installation could cause the implant to loosen early, requiring revision surgery. This affects patients who had this specific knee implant component installed.
The implant may loosen earlier than expected if the surgeon did not position it correctly or used inadequate cementing technique. This could lead to the need for revision surgery sooner than intended.
Patients who received the LINK SLED Knee System poly tibial component (13mm x 55mm, item number 15-2028/12) during surgery are affected. Those with the implant are most at risk if the surgical installation was suboptimal.
Check if your knee implant has a poly tibial component measuring 13mm x 55mm with item number 15-2028/12. The recall covers all units within the labeled expiration date.
Identify if your knee implant has a poly tibial component measuring 13mm x 55mm with item number 15-2028/12.
No, the recall does not require stopping use. Patients should consult their surgeon about whether their implant needs revision.
The recall is due to potential early loosening from improper surgical installation, which could require revision surgery sooner than expected.
Check if your implant has a poly tibial component measuring 13mm x 55mm with item number 15-2028/12.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1522-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1522-2023 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.
