FDA Enforcement
Class II
Terminated
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Recall: Z-0321-2016
·
Reported December 2, 2015
Enforcement
- Recall Number
- Z-0321-2016
- Event ID
- 72541
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 2, 2015
- Initiation Date
- October 21, 2015
- Classification Date
- November 20, 2015
- Termination Date
- June 24, 2016
- Address
- 4620 N Beach St, N/A, Haltom City, TX, 76137-3219, United States
Description
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Reason
The wire pass hole is not present on the tools.
Code Info
Catalog Number: 16TA24, Lot Number: 0006936810
Distribution
Distributed in the states of California, New York, and Texas and the country of Belgium.
Quantity
9 pieces