The Recall Desk
HighFDA (Devices)·Z-0085-2022·Announced 2021-10-20

Spinal Implant Engraving May Not Match Pouch Labels

Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a spinal surgical implant where the labeling mismatch between device engraving and pouch labels could affect proper device identification. It qualifies as a risk-of-harm product where no injuries have been reported.

Plain-English summary

Medtronic Sofamor Danek USA Inc. is recalling the Endoskeleton TAS Interbody System with Titan nanoLOCK Surface Technology (Nanolock 12 Dg Interbody, Large, 12mm). The engraving on the implants may not match what is listed on the pouch labels.

Approximately 10 units were distributed in the following U.S. states: California, Minnesota, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Washington, and West Virginia. The implants are identified as Product Number 2312-0212-N, Lot A200323.

The recalled product

Product
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Spinal Implant
Hazard
  • labeling-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Number 2312-0212-N
  • Lot A200323 GTIN 00191375014171

Distribution

Distributed in 14 states:

  • CA
  • MN
  • MO
  • NC
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • SC
  • SD
  • WA
  • WV

Related recalls

Same category