Z-2519-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2023
- Initiation Date
- July 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Reason for Recall
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
Code Information
Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215