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U.S. Department of Health and Human Services

Class 2 Device Recall Final Pack, Esteem II, Sound Processor Model 2001

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  Class 2 Device Recall Final Pack, Esteem II, Sound Processor Model 2001 see related information
Date Initiated by Firm June 28, 2018
Create Date August 01, 2018
Recall Status1 Terminated 3 on November 03, 2020
Recall Number Z-2590-2018
Recall Event ID 80489
PMA Number P090018 
Product Classification active hearing implant, middle ear - Product Code OAF
Product Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
Code Information Lot Numbers: EMC0006145, EMC0006155, & EMC0006217   
Recalling Firm/
Manufacturer		 Envoy Medical Corporation
4875 White Bear Pkwy
Saint Paul MN 55110-3325
Manufacturer Reason
for Recall		 Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
FDA Determined
Cause 2		 Packaging process control
Action The firm notified its customers via email on 06/18/2018 and 06/19/2018. The 06/18/2018 email to a customer stated Envoy Medical would like to have the devices the customer has on site returned, as apparently, it was confirmed that each device is packaged with a wipe that shows expired just on the wipe only. Envoy will replace the recalled devices by overnight shipping replacements. The 06/19/2018 email to a customer stated it was discovered that the sound processors (primary and backup) were previously sent to the site have a wipe in them that show an expired date on the packaging. The email also stated this is something that doesn't affect the actual sound processor itself as those are good, but just to be on the safe side, make sure the 2 sound processors currently at the site (serial #s 213658 and 213729) are returned to Envoy Medical ASAP so we can have them repackaged with wipes within their expiration dates added to the sound processor packaging. Envoy will send out 2 new Sound Processors (primary and backup). Both emails contained Envoy Medical contact information for the consignees in case any questions or concerns arose.
Quantity in Commerce 4 Units
Distribution US Distribution to states of: FL, OR
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 = OAF and Original Applicant = ENVOY MEDICAL CORPORATION
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