{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "175420", "product_res_number": "Z-0023-2020", "event_date_initiated": "2019-07-31", "event_date_created": "2019-10-01", "recall_status": "Terminated", "event_date_terminated": "2021-03-24", "res_event_number": "83490", "product_code": "ETN", "k_numbers": [ "K152505" ], "product_description": "C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329\n\nProduct Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.", "code_info": "All Serial Numbers are affected", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E Milham Ave", "city": "Portage", "state": "MI", "postal_code": "49002-9704", "additional_info_contact": "Kara Spath\n269-389-4518", "reason_for_recall": "Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to\nthe functionality of the device, which may result in use errors potentially causing or contributing to nerve\ninjury.", "root_cause_description": "Device Design", "action": "On July 31, 2019, the firm distributed an Urgent Medical Device Recall Notification to its consignees to inform them of the recall.\n\nCustomers were asked to do the following:\n\n1. Immediately review the Recall Notification and this Business Reply Form (BRF).\n2. Inform all users of the Stryker C2 NerveMonitor of the information contained in this recall notification.\n3. Check all treatment areas, operating rooms and/or storage areas for affected products.\n4. Determine a plan to transition to an alternative commercially available product. Document your\ntransition date on the BRF. This transition date must be no later than January 31, 2020.\n5. Complete page 2 of BRF to confirm receipt of this Notification, identify how many affected items are\ncurrently in your inventory, and provide the date you will transition to alternative product and return your\nStryker C2 NerveMonitor. Upon receipt of your returned device(s), Stryker will work with your facility to\nissue a refund or credit.\n Please complete and return the BRF even if you dont have any affected product on hand.\n6. Fax the completed BRF to Stryker Instruments at 8665212762, or email to kara.spath@stryker.com.\n7. If you have further distributed this product, please forward copies of the Notification and this BRF to all\naffected locations, for each location to complete and return. Even if you have distributed all product to\nanother location, please complete a BRF and indicate each location that received product.", "product_quantity": "135", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K870272", "K051718", "K071349", "K091874", "K040543", "K933491", "K945242", "K020955", "K021595", "K133348", "K923056", "K982595", "K121931", "K925640", "K880720", "K873964", "K831715", "K232888", "K032083", "K912508", "K110712", "K934426", "K110696", "K014165", "K062549", "K843226", "K881757", "K072736", "K112686", "K031510", "K092729", "K003745", "K110138", "K152505", "K253536", "K063560", "K103128", "K991583", "K061365", "K110422", "K100992", "K934733", "K971143", "K895676", "K954601", "K212355", "K111597", "K110989", "K992869", "K874018", "K872791", "K895838", "K102862", "K925008", "K092292", "K093373", "K050162", "K150005", "K833646", "K063305", "K251672", "K781569", "K152769", "K951641", "K112435", "K112718", "K200886", "K031003", 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