2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
FDA device recall Z-1703-2026 · posted 2026-03-30 · Open, Classified
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- 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.
- Action taken
- Depuy Synthes initially notified Sales Consultants and Regional Managers on about 02/25/2026, followed by notification of consignees. Consignees were instructed to examine inventory for affected units, quarantine them immediately, and contact Depuy Synthes sales consultant or customer support services to arrange the return/credits for affected units. Additionally, consignees were requested to complete and return the provided Business Response Form as well as notify all applicable personnel within the facility or any consignees if the affected units were further distributed. Consignees were also requested to post the notification in a visible area for awareness.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- HWX
- Quantity affected
- 33 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.
- Date initiated
- 2026-02-25
- Date posted
- 2026-03-30
- Location
- West Chester, PA
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