Linkbio recalls its ENDO model SLED TIBIAL COMP 13mm x 50mm knee implant due to potential early revision surgery from improper implant positioning or cementing. Affected patients should contact Linkbio for guidance.
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 13mm x 50mm knee implant because improper surgical placement or cementing could cause early revision surgery. This affects patients who had this specific implant installed.
The implant may loosen or wear faster if not positioned correctly during surgery or if cementing technique is inadequate. This could lead to the need for earlier revision surgery than expected.
Patients who received the Linkbio ENDO model SLED TIBIAL COMP 13mm x 50mm knee implant during surgery are most at risk. The recall applies to all units sold with the specified item number.
Check for the item number 15-2030/08 on the implant packaging or surgical label. The recall covers all units sold within the labeled expiration date.
Patients should reach out to Linkbio directly for guidance on next steps regarding their implant.
The recall is due to potential early revision surgery from improper implant positioning or inadequate cementing during surgery.
No, the recall does not require stopping use; patients should contact Linkbio for guidance.
Check for the item number 15-2030/08 on the implant packaging or surgical label. The recall covers all units sold within the labeled expiration date.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1532-2023 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.
