FDA Device recall Z-2389-2016
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Star…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Star… by Synthes Usa Products, citing it was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2389-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-28 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, WA |
Product
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4 mm Titanium Variable Angle LCP Distal Radius System - 2.7 mm/3.5 mm Titanium Distal Fibula Plate System
Reason
It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.
Identifiers
| code_info | Lot Number: 9942217 Part Number: 412.812 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2389-2016%22
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