Linkbio recalls specific knee implants due to potential early loosening or wear from improper surgical technique, requiring revision surgery. Affected models include POREX ENDO MODEL SLED TIBIAL COMP 13mm x 50mm with item number 15-2230/08.
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 loosening or wear from improper surgical placement. This could lead to revision surgery sooner than expected, which is why patients with this implant should contact the company.
The implant can loosen or wear faster if not positioned correctly during surgery or if cementing technique is inadequate. This may cause the implant to fail earlier than intended, requiring revision surgery.
Patients who received the Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM implant with item number 15-2230/08. Those who had the implant placed using suboptimal positioning or inadequate cementing techniques are at higher risk.
Check for the item number 15-2230/08 on the implant packaging or label. The product is part of the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM series.
Reach out to Linkbio directly to confirm if your implant is affected and get guidance on next steps.
The recall is due to potential early loosening or wear of the implant from improper surgical placement or inadequate cementing technique, which could lead to revision surgery.
No, the recall does not require stopping use; patients should contact Linkbio for guidance.
Contact Linkbio to determine if your implant is affected and follow their instructions.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1548-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1548-2023 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.
