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U.S. Department of Health and Human Services

Class 2 Device Recall Restoration Modular Revision Hip System,

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  Class 2 Device Recall Restoration Modular Revision Hip System, see related information
Date Initiated by Firm December 30, 2009
Date Posted March 11, 2010
Recall Status1 Terminated 3 on September 14, 2012
Recall Number Z-1102-2010
Recall Event ID 54230
510(K)Number K013106  
Product Classification hip prosthesis - Product Code LZO
Product Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.
Code Information Catalog number: 6276-5-014; Lot number: 20568201, Exp 11/23/2011.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.
FDA Determined
Cause 2		 Process control
Action Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.
Quantity in Commerce 1
Distribution 1 device distributed to a hospital in GA.
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 = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP.
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