Cochlear Nucleus Sterile Silicone Template recallZ-2155-2015 · Cochlear Americas Inc. · initiated Jun 5, 2015
Class II Terminated All recalls posted in July 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cochlear Americas Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2155-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 5, 2015
- Posted by the FDA
- Jul 20, 2015
- Recalling firm
- Cochlear Americas Inc.
- Quantity
- 26
- Product code
- MCM
- FDA submissions
- P970051
- Distribution
- US Nationwide Distribution to CO, OH, OR, MI, and CA.
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
Code information (models, lots, serial numbers)
Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15
Other devices under the same FDA submission
19 devices cleared under P970051 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cochlear® Nucleus® CI512 cochlear ImplantCochlear Limited · IMPLANT, COCHLEAR2,771 reports
- Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCochlear Limited · Implant, cochlear2,115 reports
- Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCochlear Limited · Implant, cochlear2,057 reports
- Nucleus Z60353Cochlear Limited · IMPLANT, COCHLEAR2 deaths1,815 reports
- Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCochlear Limited · IMPLANT, COCHLEAR1,475 reports
- Cochlear® Nucleus® CI612 cochlear ImplantCochlear Limited · Implant, cochlear1,150 reports
- Nucleus Z190574Cochlear Limited · IMPLANT, COCHLEAR981 reports
- Cochlear® Nucleus® CI532 cochlear Implant with Slim Modiolar electrodeCochlear Limited · IMPLANT, COCHLEAR837 reports
- Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode CI1032Cochlear Limited · Implant, cochlear87 reports
- Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrode CI1022Cochlear Limited · Implant, cochlear72 reports
- Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrodeCochlear Limited · Implant, cochlear69 reports
- Nucleus Z277598Cochlear Limited · IMPLANT, COCHLEAR36 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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