Skip to content
Recall Observatory FDA recall evidence

Device product

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

Z-1439-2021

March 17, 2021

Class II

Product summary

Firm
Medtronic Sofamor Danek USA, Inc
Event
Event 87626
Status
Terminated
Classification
Class II
Quantity
11 devices
Official record key
device-enforcement:Z-1439-2021

Official wording

Reason: The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

Code information: GTIN 00191375013006, Lot Number TM0126527

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.