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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Flat Panel Arm

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  Class 2 Device Recall Stryker Flat Panel Arm see related information
Date Initiated by Firm April 07, 2010
Date Posted May 14, 2010
Recall Status1 Terminated 3 on March 30, 2011
Recall Number Z-1605-2010
Recall Event ID 55498
Product Classification Anesthetic cabinet, table, or tray - Product Code BRY
Product Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.
Code Information Catalog number: 0682400028 Lot numbers 1003, 1004, 1005, 1006. Serial numbers from 00001-01529
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact
972-410-7310
Manufacturer Reason
for Recall		 Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at .
Quantity in Commerce 1498
Distribution Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .
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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