Synthes (USA) Products LLC: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Synthes (USA) Products LLC
- Product
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-02-25
- Code info
- Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
- Product quantity
- 77 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- West Chester
- State
- PA
- Country
- United States
- Event id
- 98461
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