MatrixMIDFACE 04.503.225.05
by Synthes
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20887587019151 | Date14 Sep 2015 | StatusListed |
Recalls
-
- Terminated Z-2739-2020
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).
-
- Terminated Z-2272-2015
The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- MatrixMIDFACE
- Generic Name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 04.503.225.05, 0450322505
- Primary DI / UDI-DI
- 20887587019151
- FDA Product Code
- DZL, JEY
- GMDN Term
- Orthopaedic bone screw (non-sliding)
- Device Class
- Class II
- Regulation Number
- 872.4880, 872.4760
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Synthes
Properties
Other properties (10)
- Sterile: 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