FDA Device recall Z-1174-2014
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation…
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation… by Synthes, citing certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1174-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-27 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
Reason
Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
Identifiers
| code_info | All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1174-2014%22
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