Z-1808-2024Class II

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

Name: Z-1808-2024 WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device
Creator: Wishbone Medical, Inc.
Published: 2024-04-05
License: https://open.fda.gov/license/

Wishbone Medical, Inc. / initiated 2024-04-05 / Open, Classified / root cause: manufacturing process

FDA source

Wishbone Medical, Inc. began a recall of WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device on 2024-04-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1808-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-05
Posted: 2024-05-10
Recalling firm: Wishbone Medical, Inc.
Product: WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Product code: OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 60 units
Distribution: US distribution to Florida, New Jersey and Connecticut.
Product codes and lots: Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1808-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1808-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-10

Product code OBT

K182704Class IIWishBone Guided Growth SystemWishbone Medical / cleared 2019-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)