Fortex Pedicle Screw System N60000481
by Xtant Medical Holdings, Inc. GUDID
Listed Open recall
Regulatory status
Recall ongoing. 1 ongoing FDA recall names this device. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM697N600004811 | Date14 Oct 2015 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
-
- Ongoing Z-1773-2026
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
-
- Terminated Z-1884-2017
The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
-
- Terminated Z-1823-2015
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
-
- Terminated Z-1512-2015
One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
Specification
- Trade Name
- Fortex Pedicle Screw System
- Generic Name
- Manual orthopaedic bender, reusable
- Model / Reference
- N60000481
- Primary DI / UDI-DI
- M697N600004811
- FDA Product Code
- MNH, MNI
- GMDN Term
- Manual orthopaedic bender, reusable
- Device Class
- Class II
- Regulation Number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Xtant Medical Holdings, Inc.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No