FDA recall Z-1808-2024

Product

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.

Distribution

US distribution to Florida, New Jersey and Connecticut.

Key facts

Status

Ongoing

Initiation date

2024-04-05

Report date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1808-2024