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U.S. Department of Health and Human Services

Class 2 Device Recall 45 Angle Driver

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 Class 2 Device Recall 45 Angle Driversee related information
Date Initiated by FirmJanuary 16, 2013
Date PostedJanuary 30, 2013
Recall Status1 Terminated 3 on September 16, 2014
Recall NumberZ-0751-2013
Recall Event ID 64129
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product45 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).
Code Information All lots
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Minneapolis MN 55441-4575
For Additional Information Contact
763-951-8181
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGreatbatch 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.
Quantity in Commerce913
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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