Linkbio recalls specific knee implant models due to risk of early loosening or wear from improper surgical technique, potentially requiring revision surgery.
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 because it can loosen or wear prematurely if not properly positioned during surgery, which might lead to needing revision surgery sooner than expected.
The implant can loosen or wear faster if not positioned correctly or cemented properly during surgery. This may cause the implant to fail earlier than intended, requiring revision surgery.
Patients who received the recalled knee implant during surgery between the specified dates. Surgeons who used the implant without proper technique are at higher risk.
Check for the model name 'SLED TIBIAL COMP 13 MM X 45 MM' and item number 15-2230/04 on the implant. The recall covers all units within the labeled expiration date.
Look for the model name 'SLED TIBIAL COMP 13 MM X 45 MM' and item number 15-2230/04 on the implant.
The recall is due to a risk of early loosening or wear from improper surgical technique, which could lead to needing revision surgery sooner than expected.
The recall does not require immediate action for the patient. However, you should check with your surgeon about the implant's condition and any necessary follow-up.
The recall does not include a fix or remedy. The issue is related to surgical technique, so proper technique by the surgeon is critical.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1545-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1545-2023 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.
