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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 64129
Product Type Devices
Status Ongoing
Recalling Firm Greatbatch Medical
City Minneapolis
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-16
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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). All lots Class II 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. 913 Z-0751-2013