Z-2499-2019Class II

Threaded Offset Cup Impactor -

Name: Z-2499-2019 Threaded Offset Cup Impactor -
Creator: Exactech, Inc.
Published: 2019-07-24
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2019-07-24 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique... on 2019-07-24. FDA classified it as Class II and gives the reason as "The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2499-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-24
Posted: 2019-09-10
Terminated: 2023-05-31
Recalling firm: Exactech, Inc.
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.
Product code: HWA Impactor
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected]. On 09/09/2019, Exactech expanded the recall to include an additional lot. Customers were notified of the expansion on about 09/09/2019.
Quantity in commerce: 22 devices
Distribution: US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
Product codes and lots: Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2499-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2499-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-18	2019-09-10

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)