Z-2499-2019 Class II Terminated
FDA device recall Z-2499-2019 was initiated by Exactech, Inc. on July 24, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 31, 2023). Affected quantity: 22 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2019
- Initiation Date
- July 24, 2019
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 devices
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.
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.
Distribution Pattern
US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
Code Information
Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001