FDA DevicesClass II
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Published: April 8, 2026Recall ID: Z-1703-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Additional Source Details
| Field | Value |
|---|---|
| City | West Chester |
| State | PA |
| Event id | 98461 |
| Address 1 | 1301 Goshen Pkwy |
| Code info | Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8. |
| Postal code | 19380-5986 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 33 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260225 |
| Initial firm notification | Letter |
| Center classification date | 20260330 |
Overview
- Recalling FirmSynthes (USA) Products LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.