Linkbio recalls specific knee implants due to risk of early loosening from improper installation. Affected units have item number 15-2230/07. Owners should contact 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 because improper installation can cause early loosening, requiring revision surgery. This affects patients who received the implant with the described item number.
The implant can loosen prematurely if not positioned correctly during surgery or if cementing technique is inadequate. This may lead to the need for earlier revision surgery than expected.
Patients who received the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM implant with item number 15-2230/07 are affected. Those who had the implant installed with suboptimal positioning or inadequate cementing are at higher risk.
Check for the item number 15-2230/07 on the implant packaging or label. The product is part of the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM.
Reach out to Linkbio Corp. for specific guidance on whether your implant is affected and next steps.
The recall addresses a risk of early loosening from improper installation, which may require revision surgery. It is not an immediate safety hazard.
Check for the item number 15-2230/07 on the implant packaging or label. The product is part of the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM.
No action is required for the implant itself. Contact Linkbio for specific guidance if you have the affected item.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1547-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1547-2023 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.
