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U.S. Department of Health and Human Services

Class 2 Device Recall Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology

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 Class 2 Device Recall Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technologysee related information
Date Initiated by FirmSeptember 02, 2021
Create DateOctober 12, 2021
Recall Status1 Terminated 3 on October 05, 2023
Recall NumberZ-0086-2022
Recall Event ID 88684
510(K)NumberK151596 K153122 K173535 K183557 K191565 K192018 
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
ProductEndoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Code Information Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490    
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information ContactVictor Rocha
901-399-2401
Manufacturer Reason
for Recall		Engraving on implants may not match what is listed on the pouch labels.
FDA Determined
Cause 2		Packaging change control
ActionA 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.
Quantity in Commerce9 units
DistributionDistribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OVE
510(K)s with Product Code = OVE
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