FDA Medical Device Recalls (openFDA)
Cochlear Americas Inc.: Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
- Recall number
- Z-2155-2015
- Recalling firm
- Cochlear Americas Inc.
- Product
- Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
- Status
- Terminated
- Initiated
- 2015-06-05
- Posted
- 2015-07-20
- Terminated
- 2015-08-05
- Reason
- Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
- Root cause
- Process control
- Action
- Cochlear sent an Urgent Medical Device Recall letter dated June 5, 2015 via Fed-Ex shipment. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected products for replacement.
- Quantity
- 26
- Distribution
- US Nationwide Distribution to CO, OH, OR, MI, and CA.
- Lot, serial or model codes
- Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
- 510(k) numbers
- not on file
- PMA numbers
- ["P970051"]
- Product code
- MCM
- Firm FEI
- 3005900820
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28