Exactech, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2499-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 24, 2019

Date Posted: September 18, 2019

Recall Number: Z-2499-2019

Event ID: 83520

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.

Status: Terminated

Product Quantity: 22 devices

Code Information:

Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001

Distribution Pattern:

US distribution to AR, CA, FL, IL, IN, NY, SC, TX.

Voluntary or Mandated:

Voluntary: Firm initiated