Synthes VOLT Locking Screw Tap recalled for incorrect thread due to packaging mix-up
Synthes shipped VOLT Locking Screw Taps with the wrong internal thread design due to a packaging error during manufacturing. The affected lot (68900P9) contains 77 units distributed across 21 U.S. states. Using the wrong tap could result in improper screw placement during orthopedic surgery.
From the FDA notice · Read the official notice ↗
What to do
- Check your inventory for Synthes part 03.424.124-US, lot 68900P9
- Do not use affected taps for any surgical procedures
- Contact your Synthes representative or distributor for instructions on returns or replacements
- Verify lot numbers before each surgical case
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 77 units
- Illnesses reported
- None reported
- Manufactured in
- 1301 Goshen Pkwy, West Chester, PA, United States
- Classification
- Class II
- Recall number
- Z-1702-2026
In the FDA's words
- Description
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. 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. Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9. 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. Affected quantity: 77 units
- 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.
2 products in this recall
Synthes VOLT bone screw taps recalled for incorrect thread
Synthes is recalling two bone screw taps, the VOLT Locking Screw Tap and the VOLT Cortex Screw Tap, because two production lots were swapped, so the taps may have an incorrect thread. The recall covers 110 units across 21 states, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. (this page)Z-1702-2026 · 77 units
- 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.Z-1703-2026 · 33 units