Linkbio recalls its LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL (Item 15-222:40) due to potential early implant loosening from improper positioning or cementing. 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 its LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL model due to a risk of early implant loosening from improper surgical placement or cementing. This could lead to revision surgery sooner than expected.
The implant may loosen earlier than expected if not positioned correctly or cemented properly during surgery. This can cause the implant to fail, requiring revision surgery sooner than planned.
Patients who received this knee implant during surgery between the product's launch and expiration date. Those with improper surgical technique or inadequate cementing are at higher risk.
Check the item number on the implant packaging: 15-2220/40. The product was sold with expiration dates within the manufacturer's specifications.
Reach out to Linkbio Corp. for specific guidance on the recall and next steps.
The recall addresses potential early implant loosening from improper surgical technique, which could lead to revision surgery. It is not an immediate safety hazard for most users.
Check the item number on the implant packaging: 15-2220/40. The product was sold with expiration dates within the manufacturer's specifications.
Contact Linkbio Corp. for specific guidance on the recall and next steps.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1539-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1539-2023 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.
