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 | Letter |
| 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 |
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