Recall Z-0827-2017
Amendia, Inc · initiated November 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zeus-P Lumbar Interbody Device
Codes / lots: Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
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.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-0827-2017
- Initiated
- November 22, 2016
- Posted by FDA
- December 20, 2016
- Terminated
- June 5, 2017
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 25 units
- Distribution
- US Distribution to the states of : GA. MI, OK, SC, TX, VA
- Recalling firm
- Amendia, Inc, Marietta, GA