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U.S. Department of Health and Human Services

Class 2 Device Recall 4mm Hex Driver

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 Class 2 Device Recall 4mm Hex Driversee related information
Date Initiated by FirmJanuary 14, 2004
Date PostedFebruary 27, 2004
Recall Status1 Terminated 3 on March 24, 2004
Recall NumberZ-0559-04
Recall Event ID 28163
510(K)NumberK020279 K024096 K031585 K031595 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
Product4mm Hex Driver
Code Information Part Number MU20012, Revision I, Lot # 02190301, 05120311
Recalling Firm/
Manufacturer		 U&I America
6132 S 380 W Ste 200
Murray UT 84107-6988
For Additional Information Contact
952-746-8080 Ext. 234
Manufacturer Reason
for Recall		Reports of hex driver tips breaking off or becoming worn or stripped.
FDA Determined
Cause 2		Other
ActionThe only consignee was notified by letter on 1/14/2003.
Quantity in Commerce300 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
510(K)s with Product Code = MNI
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