WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
FDA Recall #Z-1808-2024 — Class II — April 5, 2024
Product Description
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Reason for Recall
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.
Recalling Firm
Wishbone Medical, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
60 units
Distribution
US distribution to Florida, New Jersey and Connecticut.
Code Information
Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated