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Recall Observatory FDA recall evidence

Device product

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Z-1702-2026

February 25, 2026

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 98461
Status
Ongoing
Classification
Class II
Quantity
77 units
Official record key
device-enforcement:Z-1702-2026

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: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.

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

    reason.no_named_rule · v1.0.0

    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.