Z-3239-2017 Class II Terminated
FDA device recall Z-3239-2017 was initiated by Firefly Medical, Inc. on August 24, 2017 and is designated Class II. Reason for recall: The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cy… The recall status is terminated (terminated November 1, 2019). Affected quantity: 570 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2017
- Initiation Date
- August 24, 2017
- Termination Date
- November 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 570 units
Product Description
IVEA Product Part Number 16100 Model 500A
Reason for Recall
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Distribution Pattern
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Code Information
Serial Numbers - 100201, 100251, 100297, 100343, 100390, 100438, 100487, 100666, 100586, 100202, 100252, 100298, 100344, 100391, 100439, 100488, 100667, 100587, 100204, 100253, 100299, 100345, 100392, 100440, 100489, 100507, 100588, 100205, 100254, 100300, 100346, 100393, 100441, 100490, 100508, 100592, 100206, 100255, 100301, 100347, 100394, 100442, 100491, 100509, 100593, 100207, 100256, 100302, 100348, 100395, 100443, 100492, 100510, 100594, 100208, 100257, 100303, 100349, 100396, 100444, 100493, 100511, 100597, 100209, 100258, 100304, 100350, 100397, 100445, 100615, 100512, 100598, 100210, 100259, 100305, 100351, 100398, 100446, 100616, 100513, 100599, 100211, 100260, 100306, 100352, 100399, 100447, 100617, 100515, 100600, 100212, 100261, 100307, 100353, 100401, 100448, 100618, 100516, 100601, 100213, 100262, 100308, 100354, 100402, 100449, 100620, 100520, 100602, 100214, 100263, 100309, 100356, 100403, 100450, 100623, 100522, 100605, 100215, 100264, 100310, 100357, 100404, 100451, 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