Medtronic Sofamor Danek recalls Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology due to possible mismatch between implant engraving and pouch labels. Affected units may require verification of labels before use.
Engraving on implants may not match what is listed on the pouch labels.
Medtronic Sofamor Danek is recalling a specific type of spinal implant system because the engraving on the implants might not match what's listed on the pouch labels. This mismatch could lead to incorrect implant selection during surgery, which might affect surgical outcomes.
The engraving on the implants may not match the labels on the pouches. This mismatch could cause surgeons to select the wrong implant size or type during surgery, potentially leading to complications.
Patients who received this specific spinal implant system during surgery are likely affected. Surgeons and medical staff who use the product are at higher risk due to potential mislabeling.
Check for the product name 'Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology', model 'NanoLock, 6 Deg, Interbody, Medium, 10mm', and product number 5366-1410-N. Lot A200510 and GTIN 00191375018490 are also identifiers for this recall.
Check that the engraving on the implant matches the labels on the pouch.
The recall is for potential label mismatch, which could lead to incorrect implant selection during surgery. However, the hazard is not described as causing serious injury in normal use.
Look for the product name 'Endoskeleton TCS Interbody System with Titan nanoLOCK Surface Technology', model 'NanoLock, 6 Deg, Interbody, Medium, 10mm', and product number 5366-1410-N.
Check that the engraving on the implant matches the labels on the pouch. If there's a mismatch, contact Medtronic Sofamor Danek for further guidance.
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-0086-2022 — Medtronic Sofamor Danek Medtronic Sofamor Danek Hello, I own a Medtronic Sofamor Danek that is covered by recall Z-0086-2022 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.
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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.
