FDA-Device2019-09-18Class II
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.
Exactech, Inc.
Hazard
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Sold states
US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
Affected count
22 devices
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2499-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief