FDA recall Z-2519-2023

Zimmer, Inc. · Class II · device

Product

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

Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.

Key facts

Status
Ongoing
Initiation date
2023-07-26
Report date
2023-09-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2519-2023