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.
Recall
- Recall Number
- Z-0024-2020
- Event Number
- 83490
- Firm
- Stryker Instruments Div. of Stryker Corporation
- FEI Number
- 1811755
- Product Code
- ETN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 31, 2019
- Terminated
- March 24, 2021
- Address
- 4100 E Milham Ave, Portage, MI, 49002-9704
Description
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.
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.
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 [email protected]. 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.
US Nationwide distribution.
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