restor3d recalls a cervical cage trial kit with incorrect footprint labeling (Small labeled as Medium). The product is non-sterile and includes 3 trials. No action required as it's a labeling error.
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
restor3d is recalling a cervical cage trial kit that was labeled incorrectly as 'Small footprint' when it's actually 'Medium'. This labeling error means the kit might not be suitable for the intended use, but it does not pose a safety risk.
The kit was labeled with a 'Small footprint' designation when it actually has a 'Medium' footprint. This mismatch could lead to incorrect surgical application if the kit is used for a different size cervical cage, but the product itself is non-sterile and intended for trial purposes only.
Orthopedic surgeons and medical professionals who purchased the specific trial kit (model 6110-N01-KTS01, lot 2022030005) for cervical cage procedures. Patients using this kit are not at risk as it's a labeling error, not a safety hazard.
Check for the model number 6110-N01-KTS01 and lot number 2022030005 on the kit. The product is a non-sterile cervical cage trial kit that includes 3 trials.
Look for the model number 6110-N01-KTS01 and lot number 2022030005 on the kit.
No, this is a labeling error that does not pose a safety risk. The product is non-sterile and intended for trial purposes only.
No action is required as this is a labeling error, not a safety hazard.
Check for the model number 6110-N01-KTS01 and lot number 2022030005 on the kit.
We’ve drafted a message you can send restor3d to request your refund or repair — edit it as you like.
Subject: Recall Z-1026-2022 — restor3d restor3d Hello, I own a restor3d that is covered by recall Z-1026-2022 from restor3d. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
