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Terminated

(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.

FDA Recall Z-0657-2013 · Posted 2013-01-09

Recalling FirmStryker Communications, Inc.
Recall StatusTerminated
Product CodeFSY
Date Initiated2012-09-25
Date Terminated2013-04-22
Product QuantityUnited States: 1,082 units and Outside United States: 199 units

Reason for Recall

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

Firm Action

Stryker sent an Urgent Medical Device Correction letter dated September 25, 2012, to all affected customers. The letter identified the product, the prolem, and the action to be taken by the customer. Customers were instructed to immediately inspect their Spring Arm. If customers experienced any concerns with their Spring Arm they were instructed to contact Stryker immediately at 1-866-841-5663 to schedule a service technician to inspect and correct the Spring Arm circlips. For questions regarding this recall call 972-410-7100.

Root Cause

Equipment maintenance

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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