WishFIX Growth Plating System (Wishbone) – Implant Mislabeling (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Brand
Wishbone Medical, Inc.
Lot Codes / Batch Numbers
Model Number: TEFCS28-08-US, UDI/DI: B562TEFCS2808US0, Lot Number: 28042
Products Sold
Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Wishbone Medical, Inc. is recalling WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. due to The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On April 5, 2024 an email with an attached MEDICAL DEVICE RECALL NOTICE was sent to all Sales Representatives, Distributors, Institutions, and Physicians who have received a product from the affected lot. Immediate Actions to Take as the Customer/User: 1. Complete and return the attached response form via email (see below) or post mail to the address below. Please complete this form even if you do not have any of this product on hand. 2. Please examine your inventory for affected devices. 3. Please return any affected product either to your distributor or to WishBone Medical at: WishBone Medical, Inc., 100 Capital Drive, Warsaw, IN 46582. 4. Once the product has been received by the WishBone Medical office, customer service will confirm whether you would like replacement product sent. 5. If you have already disposed of product or if it has already been implanted, please note this on the Acknowledgement and Response Form for credit to your account. Please maintain this notice on file for your company s awareness. This recall is being conducted with the knowledge of FDA and is subject to FDA effectiveness checks.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, FL, NJ
Page updated: Jan 10, 2026