SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for

FDA device recall Z-2052-2014 · posted 2014-07-15 · Terminated

Recall details

Recalling firm

Stryker Communications

Reason for recall

During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.

Action taken

Direct accounts in the US were notified by letter dated March 21, 2014, and asked to report any malfunctions to Stryker Communications immediately. In addition, Stryker Representatives will visit all US accounts to inspect all the product units on hand. If needed, Representatives will check that black, screw/lock washers supplied by Stryker are secured in place and will replace any that are not the typed furnished by Stryker. All units will be updated with a yellow, warning sticker on the monitor bracket which reads: "Failure to properly install the screw and lock washer below can result in the attached component/equipment falling." Stryker Communications' foreign distributors will oversee notification, inspection, and corrections of their accounts and report corrections and other findings to Stryker Communications.

Root cause

Process control

Status

Terminated

Product code

BRY

Quantity affected

953 STRYKER SHAPE ARMS of all types

Distribution

Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia

Date initiated

2014-03-17

Date posted

2014-07-15

Date terminated

2015-05-15

Location

Flower Mound, TX