Recall Z-0891-2017
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
Optimus Fixed Awl
Codes / lots: Part Number 139005 - Lot Number 182-16146
Reason for recall
Complaints that the tip of the awl broke after impaction during surgery.
FDA-determined cause: Device Design
Action taken
Amendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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-0891-2017
- Initiated
- November 22, 2016
- Posted by FDA
- December 22, 2016
- Terminated
- February 28, 2017
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- 9 devices
- Distribution
- US Distribution to the states of : FL, GA. IL, MO, TX
- Recalling firm
- Amendia, Inc, Marietta, GA