FDA-Device2024-05-22Class II
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Wishbone Medical, Inc.
Hazard
The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
Sold states
US distribution to Florida, New Jersey and Connecticut.
Affected count
60 units
Manufactured in
100 Capital Dr, N/A, Warsaw, IN, United States
Products
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1808-2024Don't want to check this manually?
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