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U.S. Department of Health and Human Services

Class 2 Device Recall Medial biopsy plate

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 Class 2 Device Recall Medial biopsy platesee related information
Date Initiated by FirmJanuary 31, 2007
Date PostedFebruary 15, 2007
Recall Status1 Terminated 3 on April 13, 2012
Recall NumberZ-0516-2007
Recall Event ID 37263
510(K)NumberK041695 K052585 
Product Classification biopsy plate - Product Code LNH
ProductThe recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The medial biopsy plate, part #2414342 is packaged and sold as a part of catalogue numbers E8800BF, M3087JG, G3087JH, and M3335LA.
Code Information All lot codes
Recalling Firm/
Manufacturer		 USA Instruments Incorporated
1515 Danner Dr
Aurora OH 44202-9273
For Additional Information ContactRobert B. Smith
800-582-2145
Manufacturer Reason
for Recall		The packaging used for the Breast Biopsy plate may exhibit small holes or tears
FDA Determined
Cause 2		Other
ActionThe recalling firm notified consignees via certified letter, dated 1/31/07.
Quantity in CommerceApproximately 2200 units for all products being recalled
DistributionWorldwide, including USA, Canada, Mexico, Argentina, Australia, Austria, Bhutan, Brazil, Chile, China, Denmark, Finland, Germany, Great Britain, Greece, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Panama, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, and Turkey.
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 = LNH
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