Recall Z-1185-2016— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2016-02-05, terminated 2016-09-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher. 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.
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-05
- Terminated
- 2016-09-06
- Firm location
- Portage, MI, United States
Product description
Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
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
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