Linkbio recalls POREX ENDO MODEL SLED TIBIAL COMP 8mm x 45mm knee implants due to early loosening risks from improper installation. Affected units have specific item numbers and expiration dates.
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 it can become loose or wear out faster if not installed correctly, potentially requiring surgery sooner than expected. This affects patients who received this implant during the specified time frame.
The implant can loosen or wear out faster if not positioned correctly during surgery or if cementing technique is insufficient. This may lead to the need for earlier revision surgery than planned.
Patients who received the LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM implant with item number 15-2230/13. Those who had the implant installed using improper techniques or inadequate cementing are at higher risk.
Check for the item number 15-2230/13 on the implant packaging or label. The recall covers all units within the labeled expiration date.
Review the item number on your implant packaging or label to confirm if it matches 15-2230/13.
The recall is due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning during surgery or inadequate cementing technique, which may require earlier revision surgery.
The official recall does not specify replacement; it focuses on checking if the implant matches the item number and ensuring proper surgical technique.
The recall covers all units within the labeled expiration date, but no specific deadline for action is stated.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1552-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1552-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
