Zeus-P Lumbar Interbody Device
FDA Recall Z-0827-2017 · Posted 2016-12-20
Recalling FirmAmendia, Inc
Recall StatusTerminated
Product CodeMAX
Date Initiated2016-11-22
Date Terminated2017-06-05
Product Quantity25 units
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.
Firm Action
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
Distribution Pattern
US Distribution to the states of : GA. MI, OK, SC, TX, VA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.