Medtronic Sofamor Danek USA Inc Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171
Products Sold
Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171
Medtronic Sofamor Danek USA Inc is recalling Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody due to Engraving on implants may not match what is listed on the pouch labels.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Engraving on implants may not match what is listed on the pouch labels.
Recommended Action
Per FDA guidance
A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to rs.sdmriskmgt@medtronic.com. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have been transferred.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, MN, MO, NV, NY, NC, OH, OK, OR, PA, SC, SD, WA, WV
Page updated: Jan 10, 2026