Home / Recalls / Greatbatch Medical / Z-0751-2013

Z-0751-2013 Class II Terminated

Recalled by Greatbatch Medical — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
February 6, 2013
Initiation Date
January 16, 2013
Termination Date
September 16, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
913

Product Description

45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).

Reason for Recall

Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45¿ product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.

Distribution Pattern

Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.

Code Information

All lots

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