FDAFDA · Food and drugs·Recall number Z-0657-2013
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel and Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly.
Published January 16, 2013 · Recall initiated: September 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete e
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Communications, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, Japan, Taiwan, Canada, United Kingdom, France, Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, Philippines and Brazil.
- Lot
- Code Number and Product Name: 0682000112-SPRING ARM, LIGHT 12-18KG, 0682000211 - FLAT PANEL SPRING ARM, ONDAL SUSPENSION, 15-21KG, 0682000212 - FLAT PANEL SPRING ARM, ONDAL SUSP., 12-18KG, 0682000226 - SPRING ARM,3.5-7KG,NAVIGATION, 0682000228 - SPRING ARM, LIGHT 9-15KG, 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP, 0682001270 - 9-POLE SPRING ARM, AC 2000,15-21 KG, 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG, 0682400034 - FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG, 0682400059 - UNIVERSAL YOKE SPRING ARM RETROFIT KIT, 06824000591 - UNIVERSAL YOKE & SPRING ARM RETROFIT KIT, INT, 0682400151 - LOW CEILING SPRING ARM, 5P SIDE MOUNT, 0682400152 - LOW CEILING SPRING ARM, 9P SIDE MOUNT, 0682400169 - 5-POLE SPRING ARM AC 2000 9-15KG, CARDINAL, 0682400207 - STANDARD SPRING ARM WITH BEARING, 5P, 0682400208 - STANDARD SPRING ARM WITH BEARING, 9P, and 0682400365 - FLAT PANEL SPRING ARM WITH ERA ADAPTER BEARING.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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