FDAClass IIMay 22, 2024

WishFIX Growth Control Plating System recall

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

Why was WishFIX Growth Control Plating System recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042

Product
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Recalling firm
Wishbone Medical, Inc.
Quantity
60 units
Distribution
US distribution to Florida, New Jersey and Connecticut.
Recall date
May 22, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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