WishFIX Growth Control Plating System, Model Number:… recallZ-1808-2024 · Wishbone Medical, Inc. · initiated Apr 5, 2024
Class II Open, Classified All recalls posted in May 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wishbone Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1808-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 5, 2024
- Posted by the FDA
- May 10, 2024
- Recalling firm
- Wishbone Medical, Inc.
- Quantity
- 60 units
- Product code
- OBT
- FDA submissions
- K182704
- Distribution
- US distribution to Florida, New Jersey and Connecticut.
Product description
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Code information (models, lots, serial numbers)
Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Other devices under the same FDA submission
3 devices cleared under K182704 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EpiFIX PK-EFC0220TWishbone Medical, Inc. · Plate, Bone, Growth Control, Pediatric, Epiphysiodesis1 report
- EpiFIX PK-EFC0222TWishbone Medical, Inc. · Plate, Bone, Growth Control, Pediatric, Epiphysiodesis1 report
- EpiFIX PK-EFC0224TWishbone Medical, Inc. · Plate, Bone, Growth Control, Pediatric, Epiphysiodesis1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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