Recall archive / FDA device enforcement
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. — FDA record Z-1808-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 5, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Wishbone Medical, Inc.
- Quantity
- 60 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1808-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Florida, New Jersey and Connecticut.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 22, 2024
- Recall initiation date
- Apr 5, 2024
- Center classification date
- May 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.