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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMarch 31, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 03, 2004
Recall NumberZ-0994-04
Recall Event ID 28821
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
ProductT2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
Code Information Lot Code: K589039; K658262; K658259; K74990; K766542.
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
300 Commerce Court
Mahwah NJ 07430
For Additional Information ContactDominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		Targeting device may become distorted upon repeated autoclaving.
FDA Determined
Cause 2		Other
ActionOn March 31, 2004 recall letters and product accountability forms were sent via FedEx.
Quantity in Commerce32 devices
DistributionThere were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.
Total Product Life CycleTPLC 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.
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