Z-0321-2016 Class II Terminated
FDA device recall Z-0321-2016 was initiated by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution on October 21, 2015 and is designated Class II. Reason for recall: The wire pass hole is not present on the tools. The recall status is terminated (terminated June 24, 2016). Affected quantity: 9 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2015
- Initiation Date
- October 21, 2015
- Termination Date
- June 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 pieces
Product Description
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Reason for Recall
The wire pass hole is not present on the tools.
Distribution Pattern
Distributed in the states of California, New York, and Texas and the country of Belgium.
Code Information
Catalog Number: 16TA24, Lot Number: 0006936810