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U.S. Department of Health and Human Services

Class 2 Device Recall C2 Nerve monitor

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  Class 2 Device Recall C2 Nerve monitor see related information
Date Initiated by Firm July 31, 2019
Create Date October 01, 2019
Recall Status1 Terminated 3 on March 24, 2021
Recall Number Z-0024-2020
Recall Event ID 83490
510(K)Number K152505  
Product Classification Stimulator, nerve - Product Code ETN
Product C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319

Product 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 Information All Serial Numbers are affected
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
269-389-4518
Manufacturer Reason
for Recall		 Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
FDA Determined
Cause 2		 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. Customers were asked to do the following: 1. Immediately review the Recall Notification and this Business Reply Form (BRF). 2. Inform all users of the Stryker C2 NerveMonitor of the information contained in this recall notification. 3. Check all treatment areas, operating rooms and/or storage areas for affected products. 4. Determine a plan to transition to an alternative commercially available product. Document your transition date on the BRF. This transition date must be no later than January 31, 2020. 5. Complete page 2 of BRF to confirm receipt of this Notification, identify how many affected items are currently in your inventory, and provide the date you will transition to alternative product and return your Stryker C2 NerveMonitor. Upon receipt of your returned device(s), Stryker will work with your facility to issue a refund or credit.  Please complete and return the BRF even if you dont have any affected product on hand. 6. Fax the completed BRF to Stryker Instruments at 8665212762, or email to kara.spath@stryker.com. 7. If you have further distributed this product, please forward copies of the Notification and this BRF to all affected locations, for each location to complete and return. Even if you have distributed all product to another location, please complete a BRF and indicate each location that received product.
Quantity in Commerce 135
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ETN and Original Applicant = INOMED MEDIZINTECHNIK GMBH
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