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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Vision 3 /Stryker Vision Elect Monitor

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 Class 2 Recall
Stryker Vision 3 /Stryker Vision Elect Monitor
see related information
Date Posted January 16, 2009
Recall Status1 Terminated on January 08, 2010
Recall Number Z-0625-2009
Recall Event ID 49568
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.
Code Information All product shipped between 06/05/06 and 01/31/07.
Recalling Firm/
Manufacturer
Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound, Texas 75028-4026
Manufacturer Reason
for Recall
Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. For further information, please contact Stryker Communications Corporation by telephone at 97
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Firm began notifying consignees of recall via letter on 09/02/08. Consignees advised that a representative would shortly visit the facility to replace the shroud with one that complies with specifications. The recall letter is entitled "URGENT: Device Recall.".
Quantity in Commerce 116 units.
Distribution Worldwide distribution; Product distributed nationwide to consignees in the states of CA, FL, IL, IN, MA, MN, NC, NM, OH and TX and to the following countries: Canada, Spain and the United Kingdom,
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.
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