FDA Device Recall Z-0003-2012: Cochlear Americas Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-2012.

Recall Res Number

Z-0003-2012

Recalling Firm / Manufacturer

Cochlear Americas Inc.

FEI Number

3005900820

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-09-16

Date Posted

2011-10-03

Date Terminated

2012-07-10

Product Code

MCM

Event Number

59979

Product Quantity

33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.

Product Description Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.

Reason for Recall Cochlear implant may shut down and cease to function.

Action Details Cochlear Americas, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.

Distribution Pattern Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.

Code Information / Serial Numbers Part Number Z209051 all codes.

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1721676 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
COCHLEAR LTD. Registration: 3002806740 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
Jabil Circuit (Shanghai) Ltd. Registration: 3005210579 View Registration
COCHLEAR AMERICAS Registration: 3005900820 View Registration
STOKVIS TAPES SWEDEN Registration: 3007743836 View Registration
MEHOW INNOVATIVE LTD Registration: 3008947133 View Registration
Cochlear Ltd Registration: 3009092818 View Registration
Advanced Bionics LLC Registration: 3009762645 View Registration
FRUEH VERPACKUNGSTECHNIK AG Registration: 3010363503 View Registration
Greatbatch Medical S. de R.L. de C.V. Registration: 3011823740 View Registration
WYON AG Registration: 3012654499 View Registration
Cochlear Malaysia Sdn Bhd Registration: 3013177549 View Registration
Cochlear Americas Warehouse Registration: 3014579188 View Registration
MEHOW INNOVATIVE (HUIZHOU) LTD. Registration: 3020283264 View Registration
Advanced Bionics North American Operations Center S.A. de C.V. Registration: 3030784382 View Registration
IN-TECH ELECTRONICS LTD Registration: 3033788852 View Registration
ZHONG SHAN FIRST CITY LEATHER PRODUCTS CO., LTD. Registration: 3034170504 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
CHRISTIAN DIENER GMBH Registration: 9611813 View Registration
Cochlear Limited - Brisbane Registration: 9613646 View Registration
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH Registration: 9710014 View Registration

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Medical Device Recall: Z-0003-2012

Recall Parameters & Description

Related Establishments / Registrations

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