| Class 2 Device Recall Power Load | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = FPO
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