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U.S. Department of Health and Human Services

Class 2 Device Recall Omnifit EON Surgical Protocol

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 Class 2 Recall
Omnifit EON Surgical Protocol
see related information
Date Posted August 17, 2008
Recall Status1 Terminated on August 19, 2008
Recall Number Z-1750-2008
Recall Event ID 47764
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Omnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ
Code Information Literatur Number LSP48 4/04
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Rose Mincieli
Manufacturer Reason
for Recall
The Table 2 Broach and Neck Trial Sizing (Literature # LSP48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Styrker Branches/Agencies were notified of the incorrect information printed in the protocal on May 17, 2007 via an Important Product Correction letter. The letter requested that all incorrect copies of the protocol be located and destroyed immediately. They requested that the Acknowledgement Form be completed and faxed, and that a Stryker Orthopaedics Customer Service rep be contacted in order to reorder the destroyed product.
Quantity in Commerce 2501 units
Distribution Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.