FDA recall Z-1758-2018

Product

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

Reason for recall

There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

Distribution

US Nationwide and Canada

Key facts

Status

Terminated

Initiation date

2018-04-02

Report date

2018-05-16

Termination date

2019-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1758-2018