Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
FDA Recall Z-0900-2017 · Posted None
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeKWT
Date Initiated2016-10-25
Date Terminated2019-07-26
Product Quantity2,278 units
Reason for Recall
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Firm Action
Exactech sent an Advisory Notice on October 25, 2016, to Exactech field agents in the U.S. Agents outside of the U.S. were notified on November 2, 2016. Field agents were notified of the recall in the Advisory Notice and asked to notify their accounts that may have the recalled product in stock. Agents were required to complete and return the Field Advisory Notice Response Form within 5 working days. For further questions, please call (352) 377-1140.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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