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U.S. Department of Health and Human Services

Class 2 Device Recall WishFIX Growth Control Plating System

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  Class 2 Device Recall WishFIX Growth Control Plating System see related information
Date Initiated by Firm April 05, 2024
Date Posted May 10, 2024
Recall Status1 Open3, Classified
Recall Number Z-1808-2024
Recall Event ID 94405
510(K)Number K182704  
Product Classification Plate, bone, growth control, pediatric, epiphysiodesis - Product Code OBT
Product WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Code Information Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Recalling Firm/
Manufacturer		 Wishbone Medical, Inc.
100 Capital Dr
Warsaw IN 46582-6704
For Additional Information Contact Brandon Alger
574-306-4006
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 60 units
Distribution US distribution to Florida, New Jersey and Connecticut.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OBT and Original Applicant = WishBone Medical
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