Medtronic Sofamor Danek recalls Endoskeleton TAS Interbody System with Titan nanoLOCK Surface Technology due to engraving mismatch on implant labels. Affected units have specific product numbers and lots.
Engraving on implants may not match what is listed on the pouch labels.
Medtronic Sofamor Danek is recalling a specific spinal implant system because the engraving on the implants might not match the labels on the pouches. This mismatch could lead to confusion during surgery or implant identification.
The engraving on the implants may not match the labels on the pouches. This mismatch could cause confusion during surgery or implant identification, potentially leading to incorrect implant selection.
Patients who received this specific spinal implant system during surgery are likely affected. Surgeons and medical staff using the product are at higher risk due to potential labeling confusion.
Check for product number 2312-0212-N and lot number A200323 on the implant pouches. The GTIN is 00191375014171.
Look for product number 2312-0212-N and lot number A200323 on the implant pouches.
The engraving on the implants may not match what is listed on the pouch labels, which could cause confusion during surgery.
Check for product number 2312-0212-N and lot number A200323 on the implant pouches. The GTIN is 00191375014171.
The recall does not specify a remedy, so there is no action required beyond checking the labels.
We’ve drafted a message you can send Medtronic Sofamor Danek to request your refund or repair — edit it as you like.
Subject: Recall Z-0085-2022 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0085-2022 from Medtronic Sofamor Danek. 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.
