| Class 2 Device Recall 24mm Rotating CMount Coupler | |
Date Initiated by Firm | March 31, 2008 |
Date Posted | August 24, 2008 |
Recall Status1 |
Terminated 3 on September 17, 2008 |
Recall Number | Z-1558-2008 |
Recall Event ID |
47463 |
510(K)Number | K983566 |
Product Classification |
General & plastic surgery laparoscope - Product Code GCJ
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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 CA 95138
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For Additional Information Contact | 408-754-2124 |
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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = GCJ
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