Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-2389-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 28, 2016

Date Posted: August 17, 2016

Recall Number: Z-2389-2016

Event ID: 74719

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.

Status: Terminated

Product Quantity: 41 units

Code Information:

Lot Number: 9942217 Part Number: 412.812

Distribution Pattern:

US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated