Linkbio recalls its ENDO model SLED TIBIAL COMP knee implant due to potential early loosening from improper placement. Affected units have specific item numbers and expiration dates. Contact Linkbio for details.
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 implant because improper surgical placement or cementing could cause early loosening, requiring revision surgery. This risk affects patients who received the implant during the specified time frame.
The implant may loosen prematurely due to incorrect positioning during surgery or insufficient cementing, leading to the need for earlier revision surgery than expected. This can happen even with proper follow-up care.
Patients who received the Linkbio ENDO model SLED TIBIAL COMP knee implant during the recall period. Those with improper surgical placement or inadequate cementing are at higher risk.
Check for the item number 15-2030/07 on the implant packaging or label. The recall covers all units within the labeled expiration date.
Look for item number 15-2030/07 on the implant packaging or label.
The recall is due to potential early loosening from improper surgical placement or inadequate cementing, which could require revision surgery earlier than expected.
Check for item number 15-2030/07 on the implant packaging or label. The recall covers all units within the labeled expiration date.
No immediate action is required. The recall is for patients who received the implant during the specified time frame to ensure proper follow-up.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1531-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1531-2023 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.
