Linkbio recalls all LINK SLED Knee Systems with 9mm x 45mm poly tibial components (item 15-2028/02) due to potential early joint failure from improper implant positioning during surgery.
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 all LINK SLED Knee Systems with 9mm x 45mm poly tibial components (item number 15-2028/02) because improper surgical placement or cementing can cause early joint failure. This may require revision surgery sooner than expected.
The knee implant can loosen or wear faster if not positioned correctly during surgery or if cementing technique is inadequate. This may lead to the need for revision surgery earlier than planned.
Patients who received the LINK SLED Knee System with 9mm x 45mm poly tibial components (item number 15-2028/02) during surgery are affected. Those with improper implant positioning or inadequate cementing are at higher risk.
Check if your knee implant has a 9mm x 45mm poly tibial component with item number 15-2028/02. The product was sold with a specific expiration date and lot numbers within that date.
Look for the item number 15-2028/02 on your knee implant's packaging or documentation.
The recall does not require stopping use; it addresses potential issues from improper surgical placement.
Check your implant's item number. If it matches 15-2028/02, contact Linkbio for guidance on next steps.
The recall addresses potential early joint failure from surgical issues, but it does not indicate immediate danger to users.
We’ve drafted a message you can send Linkbio to request your refund or repair — edit it as you like.
Subject: Recall Z-1512-2023 — Linkbio Linkbio Hello, I own a Linkbio that is covered by recall Z-1512-2023 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.
