FDA Recall
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
·
Initiated October 21, 2015
Recall
- Recall Number
- Z-0321-2016
- Event Number
- 72541
- Firm
- Medtronic Sofamor Danek Usa, Inc Dallas Distribution
- FEI Number
- 1625507
- Product Code
- HBB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 21, 2015
- Terminated
- June 24, 2016
- Address
- 4620 N Beach St, Haltom City, TX, 76137-3219
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.
Action
A recall letter was mailed to consignees on October 21, 2015.
Distribution
Distributed in the states of California, New York, and Texas and the country of Belgium.
Quantity
9 pieces