The Recall Desk
HighFDA (Devices)·Z-1703-2026·Announced 2026-04-08

VOLT bone taps swapped between lots carry the incorrect thread

The 2.4 VOLT Tap Cortex Screw is being recalled after a full lot swap with the VOLT Locking Screw Tap left the bone taps with an incorrect thread.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a bone tap cutting the wrong thread would not match the screw intended for it, and no injuries are stated in the source.

Plain-English summary

The 2.4 VOLT Tap Cortex Screw to 90 mm, part number 03.424.126-US, is being recalled. About 33 units were distributed across 21 US states. The FDA has classified this recall as Class II.

A full lot swap occurred between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bone taps having an incorrect thread.

Affected product is part number 03.424.126-US.

Facilities can identify affected taps by the part and lot numbers above, and may contact the recalling firm for further information.

The recalled product

Product
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopaedic instrument
Hazard
  • lot-swap
  • incorrect-thread
  • surgical-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category