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Exactech, Inc. recalls Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system component
Recalled September 18, 2019 · FDA recall Z-2499-2019 · Exactech
Hazard
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. · FDA Class II
Units
22 devices
Sold at
US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
Description
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
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.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →