Device product
Optimus Fixed Awl
Z-0891-2017
Product summary
- Firm
- Amendia, Inc
- Event
- Event 75856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 devices
- Official record key
device-enforcement:Z-0891-2017
Official wording
Reason: Complaints that the tip of the awl broke after impaction during surgery.
Code information: Part Number 139005 - Lot Number 182-16146
Distribution pattern: US Distribution to the states of : FL, GA. IL, MO, TX
Derived failure modes
-
Unknown
Complaints that the tip of the awl broke after impaction during surgery.