Z-0566-2013Class II

The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer...

Name: Z-0566-2013 The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer...
Creator: Stryker Medical Division of Stryker Corporation
Published: 2012-10-11
License: https://open.fda.gov/license/

Stryker Medical / initiated 2012-10-11 / Terminated / root cause: design

FDA source

Stryker Medical Division of Stryker Corporation began a recall of 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 on 2012-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0566-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-11
Posted: 2012-12-19
Terminated: 2013-08-30
Recalling firm: Stryker Medical
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.
Product code: FPO Stretcher, Wheeled
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0566-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0566-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code FPO

K113598Class IIPower-Load Cot Fastener SystemStryker Medical / cleared 2011-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)