FDA Enforcement
Class II
Ongoing
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
Recall: Z-2261-2024
·
Reported July 10, 2024
Enforcement
- Recall Number
- Z-2261-2024
- Event ID
- 94755
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 10, 2024
- Initiation Date
- June 3, 2024
- Classification Date
- July 3, 2024
- Address
- 1941 Stryker Way, N/A, Portage, MI, 49002-9711, United States
Description
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
Reason
Expired Products distributed to customers
Code Info
GTIN: 07613327118438 Lot Number: 1000388946
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Quantity
8 units