Zeus-P Lumbar Interbody Device
FDA device recall Z-0827-2017 · posted 2016-12-20 · Terminated
Recall details
- Recalling firm
- Amendia, Inc
- 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.
- Action taken
- Amendia Inc. sent an Urgent - Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions please call (404) 610-7215.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 25 units
- Distribution
- US Distribution to the states of : GA. MI, OK, SC, TX, VA
- Date initiated
- 2016-11-22
- Date posted
- 2016-12-20
- Date terminated
- 2017-06-05
- Location
- Marietta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Amendia Interbody Fusion Devices (K151322) | Amendia, Inc. | 2015-09-10 |