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U.S. Department of Health and Human Services

Class 2 Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)

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 Class 2 Device Recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)see related information
Date Initiated by FirmFebruary 05, 2016
Create DateMarch 17, 2016
Recall Status1 Terminated 3 on September 06, 2016
Recall NumberZ-1184-2016
Recall Event ID 73403
510(K)NumberK140095 
Product Classification Stretcher, wheeled, powered - Product Code INK
ProductPrime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
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
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information ContactStryker Customer Service
800-327-0770
Manufacturer 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
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 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).
Quantity in Commerce36
DistributionDistributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = INK
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