Nucleus Non-Magnetic Plug for removable magnet implants… recallZ-0119-2010 · Cochlear Americas Inc. · initiated Sep 30, 2009
Terminated All recalls posted in November 2009
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 implant device component was mis-labeled.
FDA root cause category: Labeling mix-ups
What the company is doing
On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees. Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.
Recall details
- Recall number
- Z-0119-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 30, 2009
- Posted by the FDA
- Nov 2, 2009
- Recalling firm
- Cochlear Americas Inc.
- Quantity
- 10 units
- Product code
- MCM
- FDA submissions
- P970051
- Distribution
- Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.
Product description
Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Code information (models, lots, serial numbers)
Part No. Z-50100.
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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