FDA (Devices) recall action 98461
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The 2.4 VOLT Tap Cortex Screw is being recalled after a full lot swap with the VOLT Locking Screw Tap left the bone taps with an incorrect thread.
The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.