WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Summary
The FDA issued a Class II for WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic d by Wishbone Medical, Inc.. 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 indicate.
Details
Source
Device Recall
External ID
Z-1808-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Lot/Code Info: Model Number: TEFCS28-08-US; UDI/DI: B562TEFCS2808US0; Lot Number: 28042
Quantity Affected: 60 units
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.
Distribution
US distribution to Florida, New Jersey and Connecticut.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-05
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wishbone Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wishbone Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wishbone Medical, Inc. have FDA actions?
Wishbone Medical, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1808-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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