FDA Enforcement
Class II
Ongoing
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Recall: Z-1808-2024
·
Reported May 22, 2024
Enforcement
- Recall Number
- Z-1808-2024
- Event ID
- 94405
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Wishbone Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- May 22, 2024
- Initiation Date
- April 5, 2024
- Classification Date
- May 10, 2024
- Address
- 100 Capital Dr, N/A, Warsaw, IN, 46582-6704, United States
Description
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Reason
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.
Code Info
Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Distribution
US distribution to Florida, New Jersey and Connecticut.
Quantity
60 units