Linkbio recalls specific knee implants due to risk of early loosening from improper installation, requiring potential revision surgery. Affected units include POREX ENDO MODEL SLED TIBIAL COMP 13mm x 55mm with item number 15-2230/12.
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 a risk of early loosening or increased wear from improper surgical installation. This could lead to the need for earlier revision surgery than expected.
The implant may loosen or wear faster if not positioned correctly during surgery or if cementing technique is inadequate. This can cause the implant to fail earlier than intended, requiring revision surgery.
Patients who received the POREX ENDO MODEL SLED TIBIAL COMP 13mm x 55mm knee implant with item number 15-2230/12 during surgery. Those who had the implant installed with suboptimal positioning or inadequate cementing are at higher risk.
Check for the POREX ENDO MODEL SLED TIBIAL COMP 13mm x 55mm implant with item number 15-2230/12. The recall covers all units within the labeled expiration date.
Reach out to your surgeon to discuss whether your implant is affected by this recall.
No, this recall specifically applies to the POREX ENDO MODEL SLED TIBIAL COMP 13mm x 55mm implant with item number 15-2230/12.
The recall does not require replacement; it involves checking with your surgeon about potential revision surgery if the implant is affected.
Check the implant label for the specific model and item number 15-2230/12. The recall covers all units within the labeled expiration date.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1551-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1551-2023 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.
