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FDAFDA · Food and drugs·Recall number Z-1808-2024

WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.

Published May 22, 2024 · Recall initiated: April 5, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Wishbone Medical, Inc.
Distributor
US distribution to Florida, New Jersey and Connecticut.
Lot
Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Risk classification
Class II
Area (FDA)
device
Country
United States

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