Medtronic Sofamor Danek USA, Inc: Medical Device Recall in 2021 - (Recall #: Z-1440-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-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.

Product Classification:

Class II

Date Initiated: March 17, 2021

Date Posted: April 28, 2021

Recall Number: Z-1440-2021

Event ID: 87626

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.

Status: Terminated

Product Quantity: 11 devices

Code Information:

GTIN 00191375013167, Lot Number TM0126572

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated