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Medical Device Recalls
Class 2 Recall
HiResolution Bionic Ear System
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Date Recall
Initiated |
March 08, 2006
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| Date Posted |
April 11, 2006
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| Recall Number |
Z-0759-06
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| Product |
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H.
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| Code Information |
Model CI-1400-02H. Serial numbers: 350550, 350974, 350386, 350613, 350654, 350687, 350714, 350754, 350859, 350964, 350998,
351006, 351031, 351035, 351063, 351129, 351132, 351139,
350568, 350121, 350486, 350514, 350581, 350655, 350896,
350955, 350958, 350967, 350452, 350816, 350949, 350959,
350963, 351021, 351140, 350489, 350492, 350505, 350555,
350789, 350910, 250914, 350957, 351036, 350565, 351020,
350251, 350283, 350482, 350509, 350519, 350524, 350525,
350527, 350531, 350532, 350583, 350676, 350689, 351046,
350535, 350220, 350224, 350239, 350246, 350250, 350254, 350256, 350260, 350294, 351069.
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Recalling Firm/
Manufacturer |
Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar
, California
91342
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| For Addition Information Contact |
Kaoru Lee Adair
661-362-1669
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Reason For
Recall |
Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
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| Action |
The recall was initiated on 03/08/06. In North America, the clinician notification letters were distributed by fax. For other regions, an Advanced Bionics representative and/or distributor are providing notification to the affected clinicians. As part of the clinician notification process, each center was provided with a list of their affected devices. Customers were given a list of HiRes 90K implants with feedthrus from Supplier B that were shipped to their clinic and are not yet registered with Advanced Bionics. Customers were asked to return the implants listed in the attachment to Advanced Bionics according to the instructions. Customers were told not to implant any of the devices on the list. Customers were told that implants manufactured wth feedthrus from Supplier A will be delivered quickly to minimize disruptions to their schedule. Customers will be contacted through Advanced Bionics Customer Service within 48 hours to arrange retrieval of implants manufactured with feedthrus from Supplier B and replacement with implants manufactured with feedthrus from Supplier A.
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| Quantity in Commerce |
613 units for both models (186 in the U.S.), (427 ROW)
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| Distribution |
Nationwide to: AR, AL, FL, TX, NY, NE, NC, CO, GA, OH, IL, PA, IN, MN, NC, CA, HI, MA, AZ, VA, OR, SD, MI, MO, IA, UT, TN.
Worldwide to: Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cuba, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela.
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