Device product
Zeus-P Lumbar Interbody Device
Z-0827-2017
Product summary
- Firm
- Amendia, Inc
- Event
- Event 75855
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-0827-2017
Official wording
Reason: Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
Code information: Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
Distribution pattern: US Distribution to the states of : GA. MI, OK, SC, TX, VA
Derived failure modes
-
Labeling or packaging
Labeling error