FDA-Device2026-04-08Class IIPROCESSING DEFECT
Synthes 2.4 VOLT Cortex Screw recalled for incorrect thread due to lot swap
OTHERNationwide distribution
Stop using Synthes VOLT Cortex Screw lot 68982P8
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.
- 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
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.
Sold states
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 count
33 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2026More Synthes (USA) Products LLC recalls
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