Class 2 Device Recall Citation TMZF HA Hip Stem Right

• Date Initiated by Firm: November 12, 2002
• Date Posted: December 19, 2002
• Recall Status: Terminated on April 04, 2003
• Recall Number: Z-0349-03
• Recall Event ID: 25085
• 510(K)Number: K993768
• Product Classification: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
• Product: Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
• Code Information: Lot Codes: 1187701, 1233101, 1187701
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp; 359 Veterans Blvd; Rutherford NJ 07070
• For Additional Information Contact: Thomas Grzeskowiak; 201-831-5495
• Manufacturer Reason for Recall: Hip Stem Fractures in the neck area.
• FDA Determined Cause: Other
• Action: Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
• Quantity in Commerce: 16
• Distribution: Product was distributed to hospitals and Howmedica Branch reps throughout the US.
• 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 = MEH