Recall Z-0900-2017 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Exactech, Inc.
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
| Date | Oct 25, 2016 |
| Status | Terminated |
| Reason | Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 2,278 units |
| Distribution | 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, Swi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063569 | EQUINOXE REVERSE SHOULDER SYSTEM Exactech, Inc., Feb 23, 2007 |