Linkbio recalls ENDO model SLED TIBIAL COMP knee implants due to potential early revision surgery from improper implant positioning or cementing technique.
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 its ENDO model SLED TIBIAL COMP knee implants because they may cause early revision surgery if not properly positioned or cemented. This risk affects patients who received the implant during the specified time frame.
The implant may loosen or wear prematurely if not positioned correctly during surgery or if cementing technique is inadequate. This can lead to the need for earlier revision surgery than expected.
Patients who received the Linkbio ENDO model SLED TIBIAL COMP knee implant between the time of sale and expiration date are affected. Those with improper implant placement or cementing technique are at higher risk.
Check for the item number 15-2030/06 on the implant packaging or label. The recall covers all units sold within the labeled expiration date.
Look for the item number 15-2030/06 on the implant packaging or label.
The recall is due to potential early revision surgery from improper implant positioning or inadequate cementing technique.
No, the recall does not require stopping use; it involves checking implant details and consulting with your surgeon.
Check the implant for the item number 15-2030/06 and contact your surgeon to discuss potential revision needs.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1530-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1530-2023 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.
