—#175607

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.

FDA product code: HWA — Impactor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2019-07-24
Posted by FDA: 2019-09-10
Terminated: 2023-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175607. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.