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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica

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  Class 2 Device Recall Howmedica see related information
Date Initiated by Firm January 23, 2003
Date Posted May 21, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall Number Z-0858-03
Recall Event ID 25640
510(K)Number K973121  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm R.
Code Information Catalog No. 66402334 Lot MAXT
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Thomas Grzeskowiak
201-831-5495
Manufacturer Reason
for Recall		 The device is demonstrating early wear and delamination.
FDA Determined
Cause 2		 Other
Action Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.
Quantity in Commerce 1
Distribution Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.
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 = JWH and Original Applicant = HOWMEDICA CORP.
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