Synthes 2 — Class II medical device recall Z-2389-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-08-17, distributed in AR, CA, CO, DE, FL, GA, IA, IL…. It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess
| Recall number | Z-2389-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-06-28 |
| Classified | 2016-08-11 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-02-02 |
| Distributed | AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, WA |
| Quantity | 41 units |
| Reason classes | device malfunction |
| Lot numbers | 9942217 |
| Model numbers | 412.812 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2389-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.