Recall Z-2499-2019 ยท HWA Impactor
Exactech, Inc.
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
| Date | Sep 10, 2019 (initiated Jul 24, 2019) |
| Status | Terminated |
| Reason | The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. |
| Root cause | Nonconforming Material/Component |
| Action | Exactech notified customers on about 07/24/2019 via "URGENT MEDICAL DEVICE RECALL" letter. Instructions included to immediately cease distribution or use of the affected devices, provide the information to customers if further distributed, identify and quarantine any affected devices, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email at recalls@exac.com. On 09/09/2019, Exactech expanded the recall to include an additional lot. Customers were notified of the expansion on about 09/09/2019. |
| Quantity | 22 devices |
| Distribution | US distribution to AR, CA, FL, IL, IN, NY, SC, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.