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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Medical Cam bearing

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  Class 2 Device Recall Stryker Medical Cam bearing see related information
Date Initiated by Firm August 10, 2009
Date Posted November 17, 2009
Recall Status1 Terminated 3 on October 29, 2010
Recall Number Z-0283-2010
Recall Event ID 52229
Product Classification Stretcher, Wheeled - Product Code FPO
Product Stryker Medical cam bearing service parts, Stryker Medical, Portage, MI; Parts 0753-006-143, 0753-006-130 and 0853-006-130S.

For Wheeled hospital stretcher.
Code Information All such parts shipped between 10/30/08 and 03/27/2009.
Recalling Firm/
Manufacturer
Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
269-324-6581
Manufacturer Reason
for Recall
The brake/steer pedal may seize, resulting in the brakes not working.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Consignees were notified by letter dated August 10, 2009 that Stryker will contact them to upgrade the stretchers within 6 months. The recall was expanded in scope to include additional serial numbers by a second letter dated September 17, 2009, which was issued to additional consignees who had not been previously notified of the recall, as well as the consignees who had been issued the August 10, 2009 letter.
Quantity in Commerce 196
Distribution Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, Japan, Korea, Latin America, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Singapore, South Africa, Spain, Switzerland, Taiwan, and United Kingdom,
Total Product Life Cycle TPLC 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.
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