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Terminated

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

FDA Recall Z-0148-2010 · Posted 2009-11-09

Recall StatusTerminated
Product CodeFPP
Date Initiated2009-09-02
Date Terminated2011-02-16
Product Quantity65

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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