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U.S. Department of Health and Human Services

Class 2 Device Recall Polyaxial screwdriver.

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 Class 2 Device Recall Polyaxial screwdriver.see related information
Date Initiated by FirmAugust 18, 2003
Date PostedAugust 27, 2003
Recall Status1 Terminated 3 on November 19, 2003
Recall NumberZ-1183-03
Recall Event ID 27014
510(K)NumberK031585 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
ProductOptima Large Poly Screw Driver
Code Information Part Number OP20012 Revision B, Lot Numbers 04240301 and 04140302.
Recalling Firm/
Manufacturer		 U&I America
6132 South 380 West - Suite 200
Murray UT 840434355
For Additional Information Contact
801-262-3100
Manufacturer Reason
for Recall		Reports of pieces chipping off the tip of screwdriver during use.
FDA Determined
Cause 2		Other
ActionConsignee was notified by letter on 8/18/2003
Quantity in Commerce116 units.
DistributionMN
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.
510(K) Database510(K)s with Product Code = MNI
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