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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker BAM (SHAPE) ARM, RIGHT

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  Class 2 Device Recall Stryker BAM (SHAPE) ARM, RIGHT see related information
Date Initiated by Firm March 17, 2014
Date Posted July 15, 2014
Recall Status1 Terminated 3 on May 15, 2015
Recall Number Z-2056-2014
Recall Event ID 67813
Product Classification medical equipment support boom - Product Code BRY
Product BAM (SHAPE) ARM, RIGHT, 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 a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. 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.
Code Information Serial numbers 080909DB001 through 131021DB015 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.
Recalling Firm/
Manufacturer		 Stryker Communications
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact Julie Baker
972-410-7295
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 953 SHAPE Arms of all types
Distribution Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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