Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
FDA Recall Z-1184-2016 · Posted None
Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeINK
Date Initiated2016-02-05
Date Terminated2016-09-06
Product Quantity36
Reason for Recall
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
Firm Action
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).
Root Cause
Mixed-up of materials/components
Distribution Pattern
Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.