Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
- Company
- Medtronic Sofamor Danek Usa Inc
- Recall Initiated
- September 2, 2021
- Terminated
- October 5, 2023
- Recall Number
- Z-0085-2022
- Quantity
- 10 units
- Firm Location
- Memphis, TN
Reason for Recall
Engraving on implants may not match what is listed on the pouch labels.
Distribution
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Lot / Code Info
Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171
Root Cause
Packaging change control
Action Taken
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.