← FDA ENFORCEMENT
Z-1702-2026Class II

Synthes (USA) Products LLC

Recalling firm
Synthes (USA) Products LLC
Product type
Device
Status
Ongoing
Report date
2026-04-08
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.
Firm state
PA
Product quantity
77 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.