Synthes 2.4 VOLT Cortex Screw recalled for incorrect thread due to lot swap
Synthes shipped Cortical Screw Tap lot 68982P8 that was accidentally swapped with a different product lot during manufacturing. The affected screws have an incorrect thread that could cause them to fail during orthopedic surgery. The error affected 33 units distributed across multiple states.
From the FDA notice · Read the official notice ↗
What to do
- If you have Synthes VOLT Cortex Screw part number 03.424.126-US lot 68982P8, do not use it
- Check your surgical inventory for this lot number and set aside any units found
- Contact Synthes or your distributor for a replacement or instructions on return
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 33 units
- Illnesses reported
- None reported
- Manufactured in
- 1301 Goshen Pkwy, West Chester, PA, United States
- Classification
- Class II
- Recall number
- Z-1703-2026
In the FDA's words
- Description
- 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-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: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8. 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: 33 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.Z-1702-2026 · 77 units
- 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. (this page)Z-1703-2026 · 33 units