Linkbio recalls specific knee implants for potential early loosening from improper installation. Affected units have item number 15-2230/15. Owners should 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 a specific knee implant model due to risks of early loosening from improper surgical placement. This could lead to earlier surgery or revision than expected.
The implant may loosen prematurely if not positioned correctly during surgery or if cementing technique is inadequate. This could cause the implant to fail earlier than intended, requiring additional surgery.
Patients who received the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM implant with item number 15-2230/15. Those who had the implant installed with suboptimal positioning or inadequate cementing are at higher risk.
Check for the item number 15-2230/15 on the implant packaging or label. The product was sold with expiration dates within the labeled timeframe.
Reach out to Linkbio Corp. for specific guidance on the recall and next steps.
The recall is due to early aseptic loosening or increased wear from improper implant positioning or inadequate cementing during surgery.
No specific stop-use instruction is given; the recall focuses on surgical technique and potential revision needs.
Contact Linkbio Corp. directly for details about the recall and any required actions.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1554-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1554-2023 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.
