Linkbio recalls specific knee implants due to potential early loosening from improper installation. Affected models include POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM with item number 15-2230/06. 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 or wear from improper surgical technique. This could lead to revision surgery 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 earlier revision surgery than planned.
Patients who received the POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM knee implant with item number 15-2230/06. Surgeons who installed the implant may also be affected.
Check for the model name 'POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM' and item number 15-2230/06 on the implant packaging or documentation.
Look for the model name and item number on the implant packaging or documentation to confirm if it's affected.
The recall is due to potential early loosening or increased wear from improper surgical technique, which could lead to revision surgery sooner than expected.
No, the recall does not require immediate removal. Affected patients should contact Linkbio for guidance.
Check for the model name 'POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM' and item number 15-2230/06 on the implant packaging or documentation.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1546-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1546-2023 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.
