Amendia Recalls Zeus-P Lumbar Interbody Devices Due to Labeling Error
Amendia, Inc. is recalling 25 Zeus-P Lumbar Interbody Devices because three boxes had conflicting patient and primary labels.
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 the source text describes a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Amendia, Inc. is recalling 25 units of the Zeus-P Lumbar Interbody Device. The recall was initiated due to a labeling error where three boxes in inventory had conflicting patient and primary labels.
An evaluation indicated that the primary label and patient label did not match. While the primary label matched the label on the inner pouch, the patient label was incorrect. The affected units are identified by Part Number 1-110926B (Lot Number 128945) and Part Number 1-120922B (Lot Number 128946).
The devices were distributed in the United States to the states of Georgia, Michigan, Oklahoma, South Carolina, Texas, and Virginia. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these specific units.
The recalled product
- Product
- Zeus-P Lumbar Interbody Device
- Manufacturer
- Amendia, Inc
- Hazard
- Affected units
- 25
Distribution
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