CLASS II Device recall · Reported 23 Jul 2014 · FDA Enforcement Report

Bam (Shape) Arm, Right, an articulating recalled

Stryker Communications is recalling Bam (Shape) Arm, Right, an articulating, arm bracket that is attached to the service head, distributed nationwide in the US. The recall was initiated on 17 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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.

Quantity recalled953 SHAPE Arms of all types

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2056-2014
FDA event ID: 67813
Recalling firm: Stryker Communications, Flower Mound, TX
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2014
FDA classified: 15 Jul 2014
Reported: 23 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

17 Mar 2014	Recall initiated by company
15 Jul 2014	Classified by FDA	+120 days
23 Jul 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Is Bam (Shape) Arm, Right, an articulating, arm bracket that is attached to the service head recalled?

Yes. Stryker Communications recalled Bam (Shape) Arm, Right, an articulating, arm bracket that is attached to the service head on 17 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-2056-2014.

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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