Z-0827-2017 Class II Terminated
FDA device recall Z-0827-2017 was initiated by Amendia, Inc on November 22, 2016 and is designated Class II. Reason for recall: 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 la… The recall status is terminated (terminated June 5, 2017). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 22, 2016
- Termination Date
- June 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
Zeus-P Lumbar Interbody Device
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of : GA. MI, OK, SC, TX, VA
Code Information
Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946