FDAClass IIOctober 20, 2021

Endoskeleton" TCS Interbody System with Titan nanoLOCK" recall

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

Why was Endoskeleton" TCS Interbody System with Titan nanoLOCK" recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
9 units
Distribution
Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
Recall date
October 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls