FDA-Device2014-02-05Class II

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

Medtronic Sofamor Danek USA Inc
Hazard

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Sold states
US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
Affected count
7 units
Manufactured in
1800 Pyramid Place, Memphis, TN, United States
Products
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0866-2014

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