POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, I...
FDA Recall #Z-0952-2015 — Class II — December 3, 2014
Product Description
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
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.
Recalling Firm
Medtronic Sofamor Danek USA Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 units
Distribution
US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
Code Information
Lot # - CA14C107
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated