Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief s

FDA device recall Z-1081-2016 · posted 2016-03-08 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Potential for power cord to melt; hazards include electric shock and fire.

Action taken

Stryker sent an URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated November 10, 2015 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).

Root cause

Component design/selection

Status

Terminated

Product code

FNM

Quantity affected

2694

Distribution

Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.

Date initiated

2015-12-03

Date posted

2016-03-08

Date terminated

2017-05-24

Location

Portage, MI