FDA Medical Device Recalls (openFDA)
Wishbone Medical, Inc.: WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
- Recall number
- Z-1808-2024
- Recalling firm
- Wishbone Medical, Inc.
- Product
- WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
- Status
- Open, Classified
- Initiated
- 2024-04-05
- Posted
- 2024-05-10
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 60 units
- Distribution
- US distribution to Florida, New Jersey and Connecticut.
- Lot, serial or model codes
- Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
- 510(k) numbers
- ["K182704"]
- PMA numbers
- not on file
- Product code
- OBT
- Firm FEI
- 3013680140
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28