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U.S. Department of Health and Human Services

Class 2 Device Recall HiResolution Bionic Ear System

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  Class 2 Device Recall HiResolution Bionic Ear System see related information
Date Initiated by Firm March 08, 2006
Date Posted April 11, 2006
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0758-06
Recall Event ID 34873
PMA Number P960058 
Product Classification Cochlear Implant - Product Code MCM
Product The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01
Code Information Model CI-1400-01. Serial numbers: 310383, 306002, 224839, 310129, 308039, 310558, 225444, 225541, 301020, 309066, 310003, 310135, 310284, 310141, 310142, 310490, 310466, 310475, 309002, 303070, 306090, 310712, 310023, 222652, 223588, 300220, 301490, 302089, 303086, 307009, 310495, 225722, 304072, 304086, 304093, 310007, 310116, 310286, 310332, 302219, 310138, 310136, 310444, 310557, 310718, 310336, 307093, 222772, 310439, 301394, 300216, 304094, 306045, 310131, 310170, 310391, 310354, 310461, 309058, 310115, 310165, 310392, 310485, 305062, 310211, 308057, 310161, 310440, 301381, 225289, 301094, 225603, 306078, 310421, 220798, 222078, 225301, 307059, 309004, 310010, 310125, 310373, 310418, 310643, 310130, 306075, 302023, 301969, 301979, 310012, 223481, 310424, 222826, 310698, 303085, 308022, 310347, 310031, 310034, 301809, 301818, 310148, 310231, 310566, 310788, 307063, 304045, 301835, 310013, 310508, 302109, 302135, 306011, 220223, 303059, 310433, 225560, 225725, 301347, 310313, 310376, 310459, 310639, 310792, 302036, 310284, 309034, 309009, 309013, 310127, 310128, 302114, 305010, 306015, 308031, 222653, 224598, 301517, 222982, 225438, 310242, 310295, 310330, 310393, 310510, 310672, 310638, 310493, 301885, 225384, 225396, 225400, 225463, 225565, 310486, 302285.                 
Recalling Firm/
Manufacturer		 Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342
For Additional Information Contact Kaoru Lee Adair
661-362-1669
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 613 units for both models (186 in the U.S.), (427 ROW)
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.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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