Howmedica Osteonics product recalled over fire hazard

Recall date

November 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Howmedica Osteonics Corp. recalls Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepa…

Recall number

Z-0811-2020

FDA classification

Class II

Brand / firm

Howmedica Osteonics Corp.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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