Recall Z-0069-2021— Nuvasive Specialized Orthopedics Inc

Name: FDA recall Z-0069-2021
Creator: U.S. Food and Drug Administration
Published: 2020-07-24

Class II · Ongoing

Class II FDA medical device recall by Nuvasive Specialized Orthopedics Inc, initiated 2020-07-24. It names 2 FDA 510(k) clearances: K201567, K193016. Product: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).. Reason: During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system..

Recalling firm: Nuvasive Specialized Orthopedics Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-07-24
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K201567 — Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc.·cleared 2020-08-10
K193016 — PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc.·cleared 2020-05-08

K-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

NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).

Reason for recall

During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.