Device 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.
Z-2499-2019
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 83520
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 devices
- Official record key
device-enforcement:Z-2499-2019
Official wording
Reason: The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Code information: Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001
Distribution pattern: US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
Derived failure modes
-
Unknown
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.