Date Initiated by Firm |
May 17, 2007 |
Date Posted |
August 17, 2008 |
Recall Status1 |
Terminated 3 on August 19, 2008 |
Recall Number |
Z-1750-2008 |
Recall Event ID |
47764 |
Product Classification |
Orthopedic Manual Surgical Instrument Protocol - 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/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Rose 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 |
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
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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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