Linkbio recalls its ENDO model SLED Knee System (item 15-2030/10) due to potential early loosening from improper implant positioning. Affected users should contact Linkbio for guidance.
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 implants because they may loosen too soon if not positioned correctly during surgery. This could lead to needing extra surgery sooner than expected.
The implant may loosen early if not positioned correctly during surgery or if cementing technique is inadequate. This can cause the implant to fail sooner than intended, requiring revision surgery.
Patients who received the ENDO model SLED Knee System (item 15-2030/10) from Linkbio. Those with improper surgical technique or inadequate cementing are at higher risk.
Check for the item number 15-2030/10 on the implant packaging or label. The product was sold with a specific expiration date and UDI-DI code 04026575044146.
Reach out to Linkbio directly for guidance on whether your implant is affected and next steps.
The recall is due to potential early loosening from improper implant positioning or inadequate cementing during surgery, which could lead to revision surgery.
No, the recall does not require immediate discontinuation. Contact Linkbio for specific guidance based on your implant.
Look for the item number 15-2030/10 on the implant packaging or label. The product was sold with a specific expiration date and UDI-DI code 04026575044146.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1533-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1533-2023 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.
