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.
FDA Recall Z-0566-2013 · Posted 2012-12-19
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Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFPO
Date Initiated2012-10-11
Date Terminated2013-08-30
Product Quantity24
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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