FDA recall Z-0811-2020

Product

Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

Reason for recall

May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

Distribution

CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan

Key facts

Status

Terminated

Initiation date

2019-11-07

Report date

2020-01-22

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0811-2020