FDA recall Z-1464-2023

Product

VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS

Reason for recall

There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

Distribution

Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.

Key facts

Status

Ongoing

Initiation date

2023-03-22

Report date

2023-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2023