FDA-Device2023-09-13Class II
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Zimmer, Inc.
Hazard
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
Sold states
Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
Affected count
24 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2519-2023Don't want to check this manually?
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