Recall Z-2051-2023 ยท HWA Impactor
Exactech, Inc.
Exactech Ergo Impactor Handle, Catalog #321-09-05.
| Date | Jun 30, 2023 (initiated Jun 5, 2023) |
| Status | Open, Classified |
| Reason | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. |
| Root cause | Process control |
| Action | The recalling firm issued the letters via email to their U.S. agents and OUS on 6/5/2023. The letter explained the reason for recall, risk to health, how to recognize that the device may fail or has failed, the actions being taken by the recalling firm, and the actions to be taken by the customer/user. Regarding the actions being taken by the recalling firm, the letter reported they have implemented a new revision of the impactor handle to eliminate the cause of this event. Upon receipt of the attached Recall Acknowledgement Form, the recalling firm will provide the consignee with new re |
| Quantity | 784 devices |
| Distribution | Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.