New Standard Device Inc
New Standard Device Inc appears in FDA public data with 4 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1649-2022, Class II) was initiated on December 28, 2020.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1649-2022 | Class II | Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. | December 28, 2020 |
| Z-1236-2022 | Class II | 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System | June 8, 2020 |
| Z-1280-2022 | Class II | Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A | August 14, 2019 |
| Z-1824-2023 | Class II | 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 1 | July 23, 2019 |