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.
FDA Recall Z-2499-2019 · Posted 2019-09-10
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeHWA
Date Initiated2019-07-24
Date Terminated2023-05-31
Product Quantity22 devices
Reason for Recall
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Firm 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 [email protected].
On 09/09/2019, Exactech expanded the recall to include an additional lot. Customers were notified of the expansion on about 09/09/2019.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.