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).
This recall has been terminated (originally issued January 30, 2013).
- Company
- Greatbatch Medical
- Recall Initiated
- January 16, 2013
- Posted
- January 30, 2013
- Terminated
- September 16, 2014
- Recall Number
- Z-0751-2013
- Quantity
- 913
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
All lots
Root Cause
Nonconforming Material/Component
Action Taken
Greatbatch sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 15, 2012 to all affected customers. The letter described the Reason For Recall, Risk to Health, and Instructions to Customers. Advised consignees to examine their inventory and quarantine the product in question. If they have further distributed the product to notify their customers and to complete and return the "Recall Response Form". Contact the firm at 1-763-951-8235 for questions relating to this notice.