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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 31, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 03, 2004
Recall Number Z-0994-04
Recall Event ID 28821
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
Code Information Lot Code: K589039; K658262; K658259; K74990; K766542.
Recalling Firm/
Howmedica Osteonics Corp.
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Dominick Cristofolo
Manufacturer Reason
for Recall
Targeting device may become distorted upon repeated autoclaving.
FDA Determined
Cause 2
Action On March 31, 2004 recall letters and product accountability forms were sent via FedEx.
Quantity in Commerce 32 devices
Distribution There were 19 consignees which are Stryker sales representatives and subsidiaries 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.