Linkbio recalls specific knee implants due to potential early loosening from improper placement or cementing, requiring surgical revision. Affected units have item number 15-2230/02 and UDI-DI 04026575429127.
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 surgical placement or cementing can cause early loosening, leading to revision surgery. This affects patients who received the implant during the labeled expiration date.
The implant can loosen prematurely if not positioned correctly during surgery or if cementing is inadequate. This may require earlier revision surgery than expected, increasing the risk of complications.
Patients who received the Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM implant with item number 15-2230/02 are affected. Those who had the implant placed without proper technique or cementing are at higher risk.
Check for the item number 15-2230/02 on the implant packaging or label. The UDI-DI code 04026575429127 is also associated with this specific model.
Reach out to your surgeon to discuss the implant's placement and cementing technique to determine if revision surgery is needed.
The recall does not require immediate discontinuation; patients should consult their surgeon about the implant's condition.
The item number is 15-2230/02.
The recall mentions potential early revision surgery, but does not specify injury risks 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-1543-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1543-2023 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.
