Cochlear Nucleus Sterile Silicone Template Recalled for Expiration
Cochlear Americas is recalling 26 units of Nucleus Sterile Silicone Templates because expired product was distributed to specific US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving expired product, which is a documentation and labeling issue rather than a direct safety hazard like contamination or structural failure. No injuries or illnesses are reported.
Plain-English summary
Cochlear Americas Inc. is recalling 26 units of the Nucleus Sterile Silicone Template (part number Z421736) because expired product was distributed. The device is used in the sterile field during cochlear implant surgery to check the size of the periosteal pocket, the shape and depth of the implant well, and appropriate positions for tie-down holes.
The affected units are from lot numbers COH471122 (expiration 5/6/15) and COH471123 (expiration 4/24/15). The product was distributed nationwide to Colorado, Ohio, Oregon, Michigan, and California.
Healthcare providers should stop using the recalled product and contact Cochlear Americas for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device used in surgical settings.
The recalled product
- 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
- Manufacturer
- Cochlear Americas Inc.
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
Distribution
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