Device product
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Z-1808-2024
Product summary
- Event
- Event 94405
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-1808-2024
Official wording
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 information: Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Distribution pattern: US distribution to Florida, New Jersey and Connecticut.
Derived failure modes
-
Unknown
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.