medical Class II Updated 2019-09-18

Exactech, Inc. recalls Threaded Offset Cup Impactor - Product Usage: To assist the

Recalled 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.

Hazard / Issue

The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.

Issued by

FDA

Affected States: AR, CA, FL, IL, IN, NY, SC, TX
Lot/Code Info: Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001
View official government recall

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