Stryker Infinity Alignment Frame Distal Sub-Assembly recalled over sterility concerns

Recall date

June 13, 2023

Source

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

Official notice title

Wright Medical Technology, Inc. recalls Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

Recall number

Z-2105-2023

FDA classification

Class II

Brand / firm

Wright Medical Technology, Inc.

Sold / distributed

There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

Why it was recalled

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

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 Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.