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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 24, 2005
Date Posted November 01, 2005
Recall Status1 Terminated 3 on April 05, 2006
Recall Number Z-0108-06
Recall Event ID 33361
510(K)Number K970200  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish - Product Code MAY
Product Reliance PF Femoral Stem
Code Information Catalog #---Description---- # of lots:  6265-2-000, Reliance PF Hip #0/10MM, 386 lots; 6265-2-001, Reliance PF Hip #1/11MM, 484 lots; 6265-2-002, Reliance PF Hip #2/12MM, 617 lots; 6265-2-003, Reliance PF Hip #3/13MM, 692 lots; 6265-2-004, Reliance PF Hip #4/14MM, 465 lots; 6265-2-005, Reliance PF Hip #5/15MM, 299 lots; 6265-2-006, Reliance PF Hip #6/16MM, 184 lots; 6265-2-007, Reliance PF Hip #7/17MM, 138 lots.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Dominick Cristofolo
201-831 Ext. 5247
Manufacturer Reason
for Recall
The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
FDA Determined
Cause 2
Other
Action A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
Quantity in Commerce 8487 units
Distribution nationwide
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 = MAY and Original Applicant = HOWMEDICA CORP.
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