Threaded Offset Cup Impactor - Product Usage: To assist the… recallZ-2499-2019 · Exactech, Inc. · initiated Jul 24, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2499-2019
- Status
- Terminated
- Initiated by the company
- Jul 24, 2019
- Posted by the FDA
- Sep 10, 2019
- Recalling firm
- Exactech, Inc.
- Quantity
- 22 devices
- Product code
- HWA
- Distribution
- US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
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.
Code information (models, lots, serial numbers)
Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 181-02-01Exactech, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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