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.
What this means for you
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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