Reported May 22, 2024 · Ongoing

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

Wishbone Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Wishbone Medical, Inc. · 100 Capital Dr · Warsaw, IN · 46582-6704

Is this the product you have?

  • WishFIX Growth Control Plating System
  • Model NumberTEFCS28-080US. Orthopedic device
Lot codes and dates
  • Model NumberTEFCS28-08-US
  • UDI/DIB562TEFCS2808US0
  • Lot Number28042
Amount recalled
60 units

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.