Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0225-2008

Stryker Trauma wheeled stretcher, Model 1002, Stryker Medical, Portage, MI 49002

Stryker Medical / initiated 2004-11-15 / Terminated

Stryker Medical Div. of Stryker Corporation began a recall of Stryker Trauma wheeled stretcher, Model 1002, Stryker Medical, Portage, MI 49002 on . The reason FDA records is "The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0225-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
Stryker Trauma wheeled stretcher, Model 1002, Stryker Medical, Portage, MI 49002
Product code
FPO Stretcher, Wheeled
Reason for recall
The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.
FDA root cause
Component change control
Action
The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.
Quantity in commerce
81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models.
Distribution
Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
Product codes and lots
All stretchers with serial numbers beginning with 0309 through 0505.