Z-2155-2015Class II

Cochlear Nucleus Sterile Silicone Template

Name: Z-2155-2015 Cochlear Nucleus Sterile Silicone Template
Creator: Cochlear Americas Inc.
Published: 2015-06-05
License: https://open.fda.gov/license/

Cochlear Americas / initiated 2015-06-05 / Terminated / root cause: manufacturing process

FDA source

Cochlear Americas Inc. began a recall of 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... on 2015-06-05. FDA classified it as Class II and gives the reason as "Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2155-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-05
Posted: 2015-07-20
Terminated: 2015-08-05
Recalling firm: Cochlear Americas
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
Product code: MCM Implant, Cochlear
Reason for recall: Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Root cause tag: manufacturing process
FDA 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 in commerce: 26
Distribution: US Nationwide Distribution to CO, OH, OR, MI, and CA.
Product codes and lots: Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2155-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)