FDA-Device2026-04-08Class IIPROCESSING DEFECT
Synthes VOLT Locking Screw Tap recalled for incorrect thread due to packaging mix-up
What this means
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.
- 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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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
77 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2026Want us to check the next one for you?
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