Linkbio recalls Endo Model SLED TIBIAL COMP 11mm x 45mm knee implants due to risk of early loosening from improper placement. All units with item number 15-2030/03 are affected.
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 its Endo Model SLED TIBIAL COMP 11mm x 45mm knee implants because improper surgical placement or cementing can cause early loosening. This may lead to revision surgery sooner than expected.
The implant can loosen earlier than expected if not positioned correctly during surgery or if cementing technique is inadequate. This may require revision surgery sooner than planned.
Patients who received this specific knee implant during surgery are affected. Surgeons and medical staff who used the implant are at higher risk due to the surgical context.
Check for the item number 15-2030/03 on the implant packaging. The product is sold under the Linkbio brand with the specific model name.
Reach out to your surgeon to discuss whether this implant was used in your procedure.
This recall applies to patients who received the Endo Model SLED TIBIAL COMP 11mm x 45mm implant with item number 15-2030/03 during surgery.
Look for the item number 15-2030/03 on the implant packaging or documentation from your surgery.
You should contact your surgeon to determine if this implant was used in your procedure.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1528-2023 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.
