Z-0086-2022Class II

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody...

Name: Z-0086-2022 Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2021-09-02
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2021-09-02 / Terminated / root cause: packaging

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm on 2021-09-02. FDA classified it as Class II and gives the reason as "Engraving on implants may not match what is listed on the pouch labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0086-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-02
Posted: 2021-10-12
Terminated: 2023-10-05
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Product code: OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Reason for recall: Engraving on implants may not match what is listed on the pouch labels.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: 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 [email protected]. 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 commerce: 9 units
Distribution: Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Product codes and lots: Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0086-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0085-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-12
Z-0086-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-12