NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, hume
Check against the official notice below — it lists the full affected range.
Nuvasive Specialized Orthopedics Inc has recalled 229 units of PRECICE Unyte System orthopedic trauma intramedullary rods designed for the humerus (upper arm bone). The recalled devices were manufactured between April 2015 and February 2021 and have been distributed worldwide, including throughout the United States. The devices are being recalled because they lack complete biological assessments for all potential patient populations and are not indicated for use in individuals under 18 years of age.
The recalled products include trauma intramedullary rods in 8.5 mm diameter, end caps, and locking screws with specific product codes and GTIN numbers listed in the recall notice. The recall applies to all lots manufactured during the specified timeframe. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.
Reason for recall: Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. Distribution: Worldwide distribution, including U.S. Nationwide. Quantity: 229 units Lot/code info: All Lots manufactured between April 2015 to February 2021. PRECICE Unyte Product Codes (for Humerus): Trauma intramedullary rod, humerus, 8.5 mm diameter: CDH8.5-20L165; CDH8.5-20L180; CDH8.5-30L195; CDH8.5-50L210; CDH8.5-50M225; CDH8.5-50M240; CDH8.5-80M255; CDH8.5-80M270; CDH8.5-80M285; CDH8.5-80M300; end cap for trauma intramedullary humeral nail: HEC1-000; HEC2-000; HEC3-000; HEC4-000; HEC5-000; Locking screws: LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100. GTIN Number (for Humerus): 00812258022730; 00812258022747; 00812258022754; 00812258022761; 00812258022778; 00812258022785; 00812258022792; 00812258022808; 00812258022815; 00812258022822; 00812258028121; 00812258028138; 00812258028145; 00812258028152; 00812258028169; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021511; 0081
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.