FDA Medical Device Recalls (openFDA)
Exactech, Inc.: 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.
- Recall number
- Z-2499-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-07-24
- Posted
- 2019-09-10
- Terminated
- 2023-05-31
- Reason
- The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
- 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 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.
- Quantity
- 22 devices
- Distribution
- US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
- Lot, serial or model codes
- Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28