Medtronic Endoskeleton TC Interbody System Recalled for Packaging Labeling Error
Medtronic is recalling 11 Endoskeleton TC Interbody System devices because shelf boxes were mislabeled, containing the wrong size 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. The hazard is a minor labeling error regarding device size within the packaging, which fits the criteria for moderate severity involving low-risk contamination or labeling issues without reported injuries.
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, Large, 8 mm (Product Number 5146-1608-N). The recall is due to a packaging labeling error where the shelf box identified as containing a small device actually contained a large device, and the shelf box identified as containing a large device actually contained a small device.
The affected devices are identified by GTIN 00191375013167 and Lot Number TM0126572. The recall covers US Nationwide distribution. The devices are indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and specific bone graft materials.
Healthcare providers and facilities should check their inventory for the specific product number and lot number listed above. If the devices are found, they should be removed from use and returned to Medtronic Sofamor Danek USA, Inc. according to the recall instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Sofamor Danek USA, Inc
- Hazard
- 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 00191375013167
- Lot Number TM0126572
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.
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