Recall Z-2499-2019— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2019-07-24, terminated 2023-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-24
- Terminated
- 2023-05-31
- Firm location
- Gainesville, FL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.