FDA-Device2016-08-17Class II
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
Synthes (USA) Products LLC
Hazard
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.
Sold states
US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.
Affected count
41 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2389-2016Don't want to check this manually?
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