Z-1808-2024 Class II Ongoing

Recalled by Wishbone Medical, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
May 22, 2024
Initiation Date
April 5, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60 units

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.

Distribution Pattern

US distribution to Florida, New Jersey and Connecticut.

Code Information

Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042