FDA recall Z-1963-2019

Product

Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.

Reason for recall

The products do not have sufficient data to support the labeled shelf life of 10 years.

Distribution

Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan.

Key facts

Status

Terminated

Initiation date

2019-06-04

Report date

2019-07-24

Termination date

2021-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1963-2019