PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 28, 2021 Initiated: March 17, 2021 #Z-1439-2021

Product Description

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.

Reason for Recall

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.

Details

Units Affected
11 devices
Distribution
US Nationwide distribution.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Medtronic Sofamor Danek USA, Inc. Units affected: 11 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 28, 2021. Severity: Moderate. Recall number: Z-1439-2021.

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