Recalls / —

—#189290

Product

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

FDA product code

OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K151596, K153122, K173535, K183557, K191565, K192018

Affected lot / code info

Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490

Why it was recalled

Engraving on implants may not match what is listed on the pouch labels.

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm

Medtronic Sofamor Danek USA Inc

Address

1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern

Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV

Timeline

Recall initiated

2021-09-02

Terminated

2023-10-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.