Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2015 - (Recall #: Z-0952-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.

Product Classification:

Class II

Date Initiated: December 3, 2014

Date Posted: January 21, 2015

Recall Number: Z-0952-2015

Event ID: 70032

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: 24 units

Code Information:

Lot # - CA14C107

Distribution Pattern:

US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.

Voluntary or Mandated:

Voluntary: Firm initiated