Cochlear Americas Inc.: Medical Device Recall in 2015 - (Recall #: Z-2155-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 5, 2015

Date Posted: July 29, 2015

Recall Number: Z-2155-2015

Event ID: 71509

Reason for Recall:

Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

Status: Terminated

Product Quantity: 26

Code Information:

Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15

Distribution Pattern:

US Nationwide Distribution to CO, OH, OR, MI, and CA.

Voluntary or Mandated:

Voluntary: Firm initiated