FDAClass IIOctober 20, 2021

Endoskeleton" TAS Interbody System with Titan nanoLOCK" recall

Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm

Why was Endoskeleton" TAS 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 2312-0212-N, Lot A200323 GTIN 00191375014171

Product
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
10 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