Recall Z-0657-2013— Stryker Communications, Inc.

Class II FDA medical device recall by Stryker Communications, Inc., initiated 2012-09-25, terminated 2013-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: (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.. Reason: 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.

Recalling firm

Stryker Communications, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-09-25

Terminated

2013-04-22

Firm location

Flower Mound, TX, United States

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