Device product
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Z-1703-2026
Product summary
- Event
- Event 98461
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-1703-2026
Official wording
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.
Code information: Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.