FDA Enforcement
Class II
Ongoing
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500
Recall: Z-2260-2024
·
Reported July 10, 2024
Enforcement
- Recall Number
- Z-2260-2024
- 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
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point of access in the patient. Catalog Number: 1025-011-500
Reason
Expired Products distributed to customers
Code Info
GTIN: 07613327374629 Lot Number: 6659783
Distribution
US Nationwide distribution in the states of Arkansas, California, Colorado, Florida, Michigan.
Quantity
3 units