Class 2 Device Recall Howmedica

• Date Initiated by Firm: January 23, 2003
• Date Posted: May 21, 2003
• Recall Status: Terminated on December 01, 2004
• Recall Number: Z-0856-03
• 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 10mm L.
• Code Information: Catalog No. 66402322 Lot L7MP
• 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: 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