Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) 의 리콜

Recall

73403

Class 2

Z-1184-2016

2016-02-05

Terminated

United States

2016-09-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144122

The hydraulic jack assemblies (pn: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. the oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. testing was done to evaluate the jacks with incorrect oil and leak events we.

On 2/5/2016, URGENT MEDICAL DEVICE NOTIFICATION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m.-5 p.m. (ET).