Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2014 - (Recall #: Z-0866-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 3, 2014

Date Posted: February 5, 2014

Recall Number: Z-0866-2014

Event ID: 67203

Reason for Recall:

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.

Status: Terminated

Product Quantity: 7 units

Code Information:

TI13J01811

Distribution Pattern:

US Distribution in the states of CA, NC, TX, IN, NJ, and MI.

Voluntary or Mandated:

Voluntary: Firm initiated