Linkbio recalls specific knee implant models due to risk of early loosening or wear from improper surgical technique, potentially requiring revision surgery.
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 loosen or wear prematurely if not properly positioned during surgery, which might lead to earlier revision surgery. This affects patients who received this implant during the specified time frame.
The implant can loosen or wear faster than expected if not positioned correctly during surgery or if cementing technique is inadequate. This may cause the implant to fail earlier than intended, requiring additional surgery.
Patients who received the Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM implant during the labeled expiration date are most at risk. The recall applies to all units sold with the specific item number 15-2230/14.
Check for the item number 15-2230/14 on the implant packaging or label. The recall covers all units sold with the labeled expiration date.
Look for the item number 15-2230/14 on the implant packaging or label to confirm if it is recalled.
The recall is due to a risk of early loosening or wear from improper surgical positioning or cementing technique, which could lead to earlier revision surgery.
Yes, the implant is safe when properly positioned and cemented during surgery, but the recall addresses potential issues from suboptimal technique.
The recall does not require replacement; it only addresses potential risks from improper surgical technique.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1553-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1553-2023 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.
