Recall Z-0566-2013— Stryker Medical Division of Stryker Corporation

Name: FDA recall Z-0566-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-11

Class II · Terminated

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2012-10-11, terminated 2013-08-30. It names one FDA 510(k) clearance: K113598. 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.. Reason: 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..

Recalling firm: Stryker Medical Division of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-10-11
Terminated: 2013-08-30
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K113598 — POWER-LOAD COT FASTENER SYSTEMStryker Medical·cleared 2011-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.