Linkbio recalls LINK SLED Knee System (item 15-2020/46) due to potential early implant failure from improper surgical technique. Affected users should contact Linkbio for details.
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 fail earlier than expected if not properly installed. This could lead to surgery being needed sooner than planned.
The implant can loosen or wear out faster if not positioned correctly during surgery or if cementing isn't done properly. This may require revision surgery earlier than intended.
Patients who received the LINK SLED Knee System (ENDO SLED KNEE FEM COMP, MEDIUM SMALL) with item number 15-2020/46. Those who had the implant installed using suboptimal techniques are at higher risk.
Check for the product name 'ENDO SLED KNEE FEM COMP, MEDIUM SMALL' and item number 15-2020/46. The recall covers all units within the labeled expiration date.
Reach out to Linkbio for specific instructions on whether your implant is affected and next steps.
The recall is for potential early implant failure due to improper surgical technique, but it does not indicate immediate danger to users.
The recall does not require stopping use; it focuses on surgical technique and potential revision surgery.
Check for the product name 'ENDO SLED KNEE FEM COMP, MEDIUM SMALL' and item number 15-2020/46 on your implant.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1508-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1508-2023 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.
