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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Equipment Delivery System (EDS)

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 Class 2 Device Recall Stryker Equipment Delivery System (EDS)see related information
Date Initiated by FirmAugust 23, 2011
Date PostedOctober 28, 2011
Recall Status1 Terminated 3 on August 20, 2012
Recall NumberZ-0138-2012
Recall Event ID 59866
510(K)NumberK033132 
Product Classification Laparoscope, general & plastic surgery accessory - Product Code GCJ
ProductStryker 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 ContactPatricia 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 2
Process control
ActionStryker 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.
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = GCJ
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