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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 28, 2003
Date Posted May 29, 2003
Recall Status1 Terminated 3 on November 12, 2003
Recall Number Z-0901-03
Recall Event ID 26267
Product Classification Impactor - Product Code HWA
Product Trident Insert Impactor
Code Information Catalog Number: 2111-0000
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Dominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		 The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
FDA Determined
Cause 2		 Other
Action Howmedica sent recall letters and acknowledgement forms via FedEx on April 29, 2003 with return receipt.
Quantity in Commerce 1758
Distribution The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil.
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.
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