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

FDA device recall Z-1808-2024 · posted 2024-05-10 · Open, Classified

Recall details

Recalling firm

Wishbone Medical, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

OBT

Quantity affected

60 units

Distribution

US distribution to Florida, New Jersey and Connecticut.

Date initiated

2024-04-05

Date posted

2024-05-10

Location

Warsaw, IN

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