Recall Z-0827-2017— Amendia, Inc
Class II · Terminated
Class II FDA medical device recall by Amendia, Inc, initiated 2016-11-22, terminated 2017-06-05. It names one FDA 510(k) clearance: K151322. Product: Zeus-P Lumbar Interbody Device. 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..
- Recalling firm
- Amendia, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-22
- Terminated
- 2017-06-05
- Firm location
- Marietta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.