FDA DeviceClass IINotable

FDA Recall: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Date: 2026-04-08
Brand: Synthes (USA) Products LLC
Category: Medical Device
FDA Class: Class II

Description

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

Hazard

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

Remedy

77 units

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