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U.S. Department of Health and Human Services

Class 2 Device Recall 24mm Rotating CMount Coupler

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 Class 2 Recall
24mm Rotating CMount Coupler
see related information
Date Posted August 24, 2008
Recall Status1 Terminated on September 17, 2008
Recall Number Z-1558-2008
Recall Event ID 47463
Premarket Notification
510(K) Number
K983566 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.
Code Information Model Number: 1088-020-121S2 Lot Numbers: Shipped: 07L046134, 07L046144, 07L046154, 07L046164, 07L046184, 07L046194, 07L046214, 07L046224, 07L046234, 07L046244, 07L046254, 07L046274, 07L046284, 07L046294, 07L046304, 07L046324, 07L046334, 07L046344, 07L046364, 07L046374, 07L046384, 07L046394, 07L046404, 07L046414, 07L046424, 07L046454, 07L046464, and 07L046474.
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138
Manufacturer Reason
for Recall
The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Only one customer had all of the defective couplers. The firm called this customer on March 27, 2008, and asked that the 28 couplers remaining in their possession be returned.
Quantity in Commerce 28 units
Distribution Product was delivered to one consignee in Iowa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = Stryker Endoscopy
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