FDA Medical Device Recalls (openFDA)
Stryker Communications: SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
- Recall number
- Z-2054-2014
- Recalling firm
- Stryker Communications
- Product
- SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
- Status
- Terminated
- Initiated
- 2014-03-17
- Posted
- 2014-07-15
- Terminated
- 2015-05-15
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 953 TOTAL SHAPE Arms of all types
- Distribution
- Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
- Lot, serial or model codes
- Serial numbers 111108DD001 through 131115DD020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 3002975342
- Firm city
- Flower Mound
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28