FDA recall Z-0069-2021

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 for recall

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

Distribution

Worldwide distribution. US nationwide, Austria, Australia, Canada, Switzerland, Denmark, Spain, France, United Kingdom, Germany, UAE, Luxembourg, Israel, Netherlands.

Key facts

Status

Ongoing

Initiation date

2020-07-24

Report date

2020-10-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2021