Linkbio recalls LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE (Item 15-2220/60) due to potential early implant failure from improper surgical technique.
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 poor surgical placement or cementing can cause early implant failure. This means the device might need revision surgery sooner than expected.
The implant can loosen or wear faster if not positioned correctly during surgery or if cementing isn't done properly. This may lead to the need for revision surgery earlier 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 for the item number 15-2220/60 on the implant packaging or label. The product was sold with a specific expiration date that varies by lot.
Look for the item number 15-2220/60 on the implant packaging or label.
The recall is due to potential early implant failure from improper surgical placement or inadequate cementing technique, which could lead to revision surgery.
No, the recall does not require stopping use. Patients should consult their surgeon about the specific risks and next steps.
Check for the item number 15-2220/60 on the implant packaging or label. The product was sold with a specific expiration date that varies by lot.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1542-2023 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.
