Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1439-2021·Announced 2021-04-28

Medtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling

Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes misidentify the size of the contained device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (misidentification of device size) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Medtronic Sofamor Danek USA, Inc. is recalling 11 units of the Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm (Product Number 5146-1208-N). The recall is due to a labeling error where the shelf box identifies a small device but actually contains a large device, and the shelf box identifying a large device actually contains a small device.

The affected devices are identified by GTIN 00191375013006 and Lot Number TM0126527. The products were distributed nationwide in the United States. These devices are indicated for use in the cervical spine with supplemental fixation and specific bone graft materials.

Healthcare providers and facilities should stop using the affected devices and contact Medtronic for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

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…
Manufacturer: Medtronic Sofamor Danek USA, Inc
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

GTIN 00191375013006
Lot Number TM0126527

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Medtronic Sofamor Danek USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Medtronic Sofamor Danek USA, Inc

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