Z-1808-2024 Class II Ongoing
FDA device recall Z-1808-2024 was initiated by Wishbone Medical, Inc. on April 5, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 60 units.
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