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U.S. Department of Health and Human Services

Class 2 Device Recall Power Load

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  Class 2 Device Recall Power Load see related information
Date Initiated by Firm October 11, 2012
Date Posted December 19, 2012
Recall Status1 Terminated 3 on August 30, 2013
Recall Number Z-0566-2013
Recall Event ID 63604
510(K)Number K113598  
Product Classification Stretcher, wheeled - Product Code FPO
Product The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
Code Information Item 6390000000 Serial Numbers: 120940217 120940257 120940259 120940260 120940261 120940275 120940276 120940277 120940290 120940291 120940292 120940293 120940294 120940431 120940435 120940436 120940437 120940448 120940449 120940454 120940458 120940459 120940203 120940258
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage MI 49002
For Additional Information Contact Renata Sila
269-324-6609
Manufacturer Reason
for Recall		 Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.
FDA Determined
Cause 2		 Component design/selection
Action All in process and Load Switch Slides within Stryker control were quarantined on 09/27/2012. Direct accounts were telephoned beginning 10/26/2012 with "Urgent Medical Device Correction" notices sent beginning on 11/30/2012. The notices explained the reason for the recall, hazards involved, and recommended actions. Stryker field service was to contact consignees to schedule replacement of the affected load switch slide. Consignees were asked to forward a copy of his notice to the new users and advise Stryker of their new location. Questions or concerns should be directed to (269) 389-6927 or (269) 389-6954.
Quantity in Commerce 24
Distribution USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.
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.
510(K) Database 510(K)s with Product Code = FPO and Original Applicant = STRYKER MEDICAL
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