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Recall Observatory FDA recall evidence

Device product

Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

Z-1185-2016

February 05, 2016

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 73403
Status
Terminated
Classification
Class II
Quantity
36
Official record key
device-enforcement:Z-1185-2016

Official wording

Reason: 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

Code information: The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15

Distribution pattern: Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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