Z-0891-2017 Class II Terminated
FDA device recall Z-0891-2017 was initiated by Amendia, Inc on November 22, 2016 and is designated Class II. Reason for recall: Complaints that the tip of the awl broke after impaction during surgery. The recall status is terminated (terminated February 28, 2017). Affected quantity: 9 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 22, 2016
- Termination Date
- February 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 devices
Product Description
Optimus Fixed Awl
Reason for Recall
Complaints that the tip of the awl broke after impaction during surgery.
Distribution Pattern
US Distribution to the states of : FL, GA. IL, MO, TX
Code Information
Part Number 139005 - Lot Number 182-16146