Linkbio recalls specific knee implants due to potential early loosening or wear from improper installation, risking revision surgery. Affected models include POREX ENDO MODEL SLED TIBIAL COMP 11mm x 55mm with item number 15-2230/11.
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, which could lead to revision surgery. This affects patients who received the implant during the specified time frame.
The implant may loosen or wear prematurely if not positioned correctly or cemented properly during surgery. This can cause the implant to fail earlier than expected, requiring additional surgery.
Patients who received the Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM implant with item number 15-2230/11. Those who had the implant installed during the product's labeled expiration date are most at risk.
Check for the model name 'POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM' and item number 15-2230/11 on the implant. The product was sold with a labeled expiration date.
Reach out to your surgeon to discuss whether your implant matches the recalled model and item number.
The recall does not require immediate discontinuation; patients should contact their surgeon to assess if the implant needs revision.
The item number for the recalled implant is 15-2230/11.
The recall mentions potential early revision surgery but does not indicate a risk of serious injury in normal use.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1550-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1550-2023 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.
