FDA Enforcement
Class II
Terminated
Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Recall: Z-0776-2020
·
Reported January 15, 2020
Enforcement
- Recall Number
- Z-0776-2020
- Event ID
- 84405
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nextremity Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2020
- Initiation Date
- November 11, 2019
- Classification Date
- January 3, 2020
- Termination Date
- September 10, 2020
- Address
- 6210 N Buffalo St, N/A, Warsaw, IN, 46580, United States
Description
Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Reason
Components 2mm shorter than indicated on the package label
Code Info
Lot Number: M1266 UDI: 00817701023159
Distribution
Nationwide
Quantity
87 units