Recall Z-1808-2024— Wishbone Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Wishbone Medical, Inc., initiated 2024-04-05. It names one FDA 510(k) clearance: K182704. Product: WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.. 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..
- Recalling firm
- Wishbone Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-05
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.