Recall Z-1702-2026— Synthes (USA) Products LLC
Class II · Ongoing
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2026-02-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.. Reason: 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..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-25
- Firm location
- West Chester, PA, United States
Product description
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.