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ENDOSKELETON TC nanoLOCK Surface Technology recallZ-1440-2021 · Medtronic Sofamor Danek USA, Inc · initiated Mar 17, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Packaging process control

What the company is doing

The firm initiated the recall by letter on 03/19/2021, The letter requested that the consignee locate and isolate the impacted product and contact the Medtronic Sales Representative to coordinate the return and replacement of the device.

Recall details

Recall number
Z-1440-2021
Status
Terminated
Initiated by the company
Mar 17, 2021
Recalling firm
Medtronic Sofamor Danek USA, Inc
Quantity
11 devices
Product code
MAX
FDA submissions
K141953, K192018, K183557
Distribution
US Nationwide distribution.

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.

Code information (models, lots, serial numbers)

GTIN 00191375013167, Lot Number TM0126572

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

22 devices cleared under K141953, K192018, K183557 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 87626).

Sources and updates

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