MicroPort Orthopedics Inc.: Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36

Hazard

Due to products not having FDA Premarket authorization to be distributed within the United States.

Details from the source

Reason for recall: Due to products not having FDA Premarket authorization to be distributed within the United States. Distribution: The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China. Quantity: 91 Lot/code info: Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361

UPC codes

00192629320130

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.