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U.S. Department of Health and Human Services

Class 3 Device Recall M/DN Intramedullary Fixation Humeral Nail

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  Class 3 Device Recall M/DN Intramedullary Fixation Humeral Nail see related information
Date Initiated by Firm March 16, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-1004-04
Recall Event ID 28623
510(K)Number K965098  
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Product M/DN Intramedullary Fixation Humeral Nail
Code Information Catalog no. 00-2254-195-09 Lot # 20118000
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Connie Morgan
574-372-4269
Manufacturer Reason
for Recall		 One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
FDA Determined
Cause 2		 Other
Action Units were distributed to twelve (12) consignees in the US and seven (7) foreign consignees (China, Japan, Korea, El Salvador, Singapore, Taiwan and UK)
Quantity in Commerce 33 units
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HSB and Original Applicant = ZIMMER, INC.
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