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Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251.

FDA device recall Z-0148-2010 · posted 2009-11-09 · Terminated

Recall details

Recalling firm
Stryker Medical Div. of Stryker Corporation
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.
Action taken
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.
Root cause
Device Design
Status
Terminated
Product code
FPP
Quantity affected
65
Distribution
Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.
Date initiated
2009-09-02
Date posted
2009-11-09
Date terminated
2011-02-16
Location
Portage, MI

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