FDA Enforcement
Class II
Terminated
Optimus Fixed Awl
Recall: Z-0891-2017
·
Reported December 28, 2016
Enforcement
- Recall Number
- Z-0891-2017
- Event ID
- 75856
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Amendia, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2016
- Initiation Date
- November 22, 2016
- Classification Date
- December 22, 2016
- Termination Date
- February 28, 2017
- Address
- 1755 W Oak Pkwy, N/A, Marietta, GA, 30062-2260, United States
Description
Optimus Fixed Awl
Reason
Complaints that the tip of the awl broke after impaction during surgery.
Code Info
Part Number 139005 - Lot Number 182-16146
Distribution
US Distribution to the states of : FL, GA. IL, MO, TX
Quantity
9 devices