Class 2 Device Recall Stryker Equipment Delivery System (EDS)

• Date Initiated by Firm: August 23, 2011
• Date Posted: October 28, 2011
• Recall Status: Terminated on August 20, 2012
• Recall Number: Z-0138-2012
• Recall Event ID: 59866
• 510(K)Number: K033132
• Product Classification: Laparoscope, general & plastic surgery accessory - Product Code GCJ
• Product: Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208; ; Stryker EDS (Equipment Delivery System) Booms and Flat Panel Suspensions are intended for use as ceiling-mounted devices to support or position equipment, monitors, cameras or light heads and/or deliver gases and/or electricity to these equipments. They are available in articulating and non-articulating configurations, in single or tandem (pair) configuration, with different shelves configuration to allow various load capacities.
• Code Information: Catalog Number: 0682000383, 0682000384, 0682000385 (A-D), 0682000386 (A-D), 0682000426, 0682000429 (A-D), 0682000326, 0682000311, 0682000361, 0682000362, 0682000230, 0682000337, 0682000338, 0682000232, 0682000233, 0682000339, 0682000234, 0682000235, 0682000236, 0682000340, 0682000341, 0682000238, 0682000239, 0682000342, 0682000240, 0682000241, 0682000931, 0682000343, 0682000344, 0682000328, 0682000933, 0682000345, 0682000329, 0682000330, 0682000934, 0682000346, 0682000347, 0682000331, 0682000936, 0682000348, 0382000332, 0682000333, 0682000401, 0682000302, and 0682000327. All product distributed and installed between July 2004 and March 2011.
• Recalling Firm/ Manufacturer: Stryker Communications Corp; 1410 Lakeside Pkwy Ste 100; Flower Mound TX 75028-4026
• For Additional Information Contact: Patricia Brown; 972-410-7310
• Manufacturer Reason for Recall: Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
• FDA Determined Cause: Process control
• Action: Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.
• Distribution: Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GCJ and Original Applicant = STRYKER COMMUNICATIONS CORP.