Linkbio recalls its ENDO model SLED Knee System (13mm x 45mm) due to potential early implant loosening from improper surgical technique. Affected units include all lot numbers with item number 15-2030/04.
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 Knee System knee implant because it can loosen early if not positioned correctly during surgery. This could lead to needing revision surgery sooner than expected.
The implant may loosen prematurely if not positioned correctly or cemented properly during surgery. This can cause the implant to fail earlier than intended, requiring revision surgery.
Patients who received this specific knee implant during surgery are affected. Surgeons who used the implant without proper technique are at higher risk.
Check for the item number 15-2030/04 on the implant packaging. All lot numbers are affected, but the specific model is the ENDO SLED TIBIAL COMP 13 MM X 45 MM.
Reach out to Linkbio Corp. for guidance on whether your implant requires revision or additional steps.
The recall is due to potential early implant loosening from improper surgical positioning or cementing technique, which could lead to revision surgery.
No, the recall does not require stopping use. Patients should contact Linkbio for guidance on whether revision surgery is needed.
Check for the item number 15-2030/04 on the implant packaging. All lot numbers are affected for this specific model.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1529-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1529-2023 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.
