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Recall Observatory FDA recall evidence

Device product

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

Z-0085-2022

September 02, 2021

Class II

Product summary

Firm
Medtronic Sofamor Danek USA Inc
Event
Event 88684
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0085-2022

Official wording

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

Code information: Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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