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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Medical StairPRO Stair Chair

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  Class 2 Device Recall Stryker Medical StairPRO Stair Chair see related information
Date Initiated by Firm September 02, 2009
Date Posted November 09, 2009
Recall Status1 Terminated 3 on February 16, 2011
Recall Number Z-0148-2010
Recall Event ID 53251
Product Classification Stretcher, Hand-Carried - Product Code FPP
Product Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251.
Code Information Serial numbers 080639995, 080640003, 081039395, 080639996, 080640004, 081039396, 080639997, 080739856, 081039397, 080639998, 080739857, 081039398, 080639999, 080739858, 081039399, 080640000, 080739859, 081039400, 080640001, 080739860, 081039401,  080640002, 080740001, 081039402, 080439860, 080439861, 080439862, 080439863, 080439864, 080439865, 080439866, 080439867, 080441124, 080439868, 080541216, 080541293, 080541294, 080541295, 080541296, 080541297, 080541298, 081039403,  081039404, 081040900, 081040901, 081040902, 090139365, 090139366, 090139367, 090139368, 090139369, 090139373, 090140687, 090140691, 090140692, 090140693, 090140694, 090140688, 090140695, 090140689, 090140696, 090140690, 090241071, 090241072 and 090241073.  
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 East Centre Ave.
Portage MI 49002
For Additional Information Contact
269-324-6609
Manufacturer Reason
for Recall		 The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.
FDA Determined
Cause 2		 Device Design
Action Consignees were sent a letter titled URGENT MEDICAL DEVICE CORRECTION dated 9/9/09, advising them of the problem and to remove the devices from service until they have been repaired. U.S. customers were notified that Stryker will complete the correction while international customers were sent a kit with instructions for completion of the correction. International consignees were told that Stryker will complete the correction if the consignee does not feel comfortable in doing so. Questions or comments regarding this issue should be addressed to Sarah Marie Puterbaugh of Stryker Medical at (800) 869-0770 ext. 6902.
Quantity in Commerce 65
Distribution Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland 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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