Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system component

FDA device recall Z-2499-2019 · posted 2019-09-10 · Terminated

Recall details

Recalling firm

Exactech, Inc.

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.

Action taken

Exactech notified customers on about 07/24/2019 via "URGENT MEDICAL DEVICE RECALL" letter. Instructions included to immediately cease distribution or use of the affected devices, provide the information to customers if further distributed, identify and quarantine any affected devices, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email at recalls@exac.com. On 09/09/2019, Exactech expanded the recall to include an additional lot. Customers were notified of the expansion on about 09/09/2019.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HWA

Quantity affected

22 devices

Distribution

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

Date initiated

2019-07-24

Date posted

2019-09-10

Date terminated

2023-05-31

Location

Gainesville, FL