Recall Z-2155-2015— Cochlear Americas Inc.
Class II · Terminated
Class II FDA medical device recall by Cochlear Americas Inc., initiated 2015-06-05, terminated 2015-08-05. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed..
- Recalling firm
- Cochlear Americas Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-05
- Terminated
- 2015-08-05
- Firm location
- Centennial, CO, United States
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
Reason for recall
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.