Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the
FDA device recall Z-2155-2015 · posted 2015-07-20 · Terminated
Recall details
- Recalling firm
- Cochlear Americas Inc.
- Reason for recall
- Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MCM
- Quantity affected
- 26
- Distribution
- US Nationwide Distribution to CO, OH, OR, MI, and CA.
- Date initiated
- 2015-06-05
- Date posted
- 2015-07-20
- Date terminated
- 2015-08-05
- Location
- Centennial, CO
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