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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 Device Recall Omnifit EON Surgical Protocolsee related information
Date Initiated by FirmMay 17, 2007
Date PostedAugust 17, 2008
Recall Status1 Terminated 3 on August 19, 2008
Recall NumberZ-1750-2008
Recall Event ID 47764
Product Classification Orthopedic Manual Surgical Instrument Protocol - Product Code LXH
ProductOmnifit EON Surgical Protocol; Literature Number: LSP48 4/04 Stryker Howmedica Osteonics Corp., Mahwah, NJ
Code Information Literatur Number LSP48 4/04 
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactRose Mincieli
201-831-5832
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		Labeling design
ActionStyrker 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 Commerce2501 units
DistributionWorldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.
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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