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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PowerPRO

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  Class 2 Device Recall Stryker PowerPRO see related information
Date Initiated by Firm August 29, 2006
Date Posted September 22, 2006
Recall Status1 Terminated 3 on April 18, 2007
Recall Number Z-1513-06
Recall Event ID 36149
Product Classification Ambulance Cot - Product Code FPO
Product Stryker Power-PRO Powered Ambulance Cot, Model 6500.
Code Information All units with a serial number lower than 060739380. (units manufactured between 1 Oct 2005 and 15 July 2006)
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact Renata Sila
800-669-4968 Ext. 6689
Manufacturer Reason
for Recall		 The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out.
FDA Determined
Cause 2		 Other
Action Consignees were notified of the recall via letter dated 8/29/06. Included with the letter were replacement bolts for each cot and installation instructions, but the customer was given the option of contacting the recalling firm for installation.
Quantity in Commerce 1,841 cots (44 foreign)
Distribution Worldwide distribution ---- including USA and countries of Canada, China, Germany and Switzerland.
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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