FDA recall Z-0705-2022

Product

Everest MI XT Inner Dilator, Catalog Number 5101-90167

Reason for recall

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status

Ongoing

Initiation date

2022-01-13

Report date

2022-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Leesburg, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2022