Reason for Recall
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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Recall NumberZ-1038-2026ClassificationClass IIStatusOngoingCategorydeviceInitiated2025-10-29Reported2026-01-21DistributionUS Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.Code InfoLot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.