Linkbio recalls specific knee implants due to potential early revision surgery from improper implant positioning or cementing. Affected models include ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM with item number 15-2030/11. No immediate action needed but consult your 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 a specific knee implant model due to risks of early revision surgery from improper implant placement or cementing. This could lead to surgery being needed sooner than expected.
The implant can loosen or wear faster if not positioned correctly during surgery or if cementing technique is inadequate. This may require revision surgery sooner than intended, but does not cause immediate harm.
Patients who received the ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM knee implant with item number 15-2030/11. Those with the implant may be at risk of needing revision surgery earlier than planned.
Check for the model name 'ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM' and item number 15-2030/11 on the implant packaging or documentation. The recall covers all units within the labeled expiration date.
Review the implant model and item number on your documentation to confirm if it matches the recalled version.
The recall does not require stopping use; it involves monitoring for potential revision surgery needs.
Contact your surgeon to discuss whether revision surgery might be needed earlier than expected.
The recall includes updated surgical training and techniques to reduce risks, but no specific fix for existing implants.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1534-2023 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.
