Linkbio recalls LINK SLED Knee System (item 15-2020/40) due to potential early implant loosening from improper surgical technique. Affected patients should consult their surgeon for possible revision.
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 (item 15-2020/40) because improper surgical placement or cementing could cause the knee implant to loosen prematurely. This might require earlier revision surgery than expected.
The implant can loosen early if the surgeon positions it incorrectly or uses inadequate cementing technique. This might lead to the need for revision surgery sooner than planned.
Patients who received the LINK SLED Knee System (item 15-2020/40) during surgery are affected. Those with the implant may face earlier revision surgery if the implant loosens.
Check for the item number 15-2020/40 on the packaging or surgical label. The recall covers all units within the labeled expiration date.
Contact your surgeon to determine if you have the recalled implant and whether revision surgery is needed.
The recall addresses potential early implant loosening from improper surgical technique, which could lead to earlier revision surgery. It is not an immediate safety hazard for users.
No, the recall does not require stopping use. Patients should consult their surgeon about whether revision surgery is needed.
Check for the item number 15-2020/40 on the packaging or surgical label. The recall covers all units within the labeled expiration date.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1507-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1507-2023 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.
