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
- Affected units
- 10
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
Part of a larger recall action
This product is one of 2 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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