Stryker Howmedica Osteonics Corp. recalls Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component

Recall date

June 25, 2015

Source

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

Recall number

Z-2810-2015

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

Distributed in WI.

Why it was recalled

it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

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

What was recalled

Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component