CLASS II Device recall · Reported 23 Jul 2014 · FDA Enforcement Report
Shape Arm, Single, an articulating recalled by Stryker Communications
Stryker Communications is recalling Shape Arm, Single, an articulating, arm bracket that is attached to the service head of, 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
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-2052-2014
- 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
SHAPE ARM, SINGLE, 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 0682400253 and the Arm part number in the kit is P17085. . 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
Questions about this recall
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 111018DE001 through 140210DE020 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 67813This product is part of a recall event; the main page for the event is Shape Arm, Single With Gcx Mount, an articulating recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Shape Arm, Single With Gcx Mount, an articulating recalled | Stryker Communications | Other | Nationwide | |
| CLASS II | Shape Arm, Dual SH2, an articulating recalled by Stryker Communications | Stryker Communications | Other | Nationwide | |
| CLASS II | Bam (Shape) Arm, Right, an articulating recalled | Stryker Communications | Other | Nationwide | |
| CLASS II | Bam (Shape) Arm, Left, an articulating recalled | Stryker Communications | Other | Nationwide |
More recalls from Stryker Communications
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker Chromophare Softlit Ring Surgical Light System recalled | Stryker Communications | Device Malfunction | Nationwide |
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Potency & Assay | TX |
| Device | CLASS II | S-Series Equipment Management System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Berchtold Chromophare Ceiling Mounted Surgical Light System recalled | Stryker Communications | Other | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |