Exactech, Inc. recalls 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the…

Recall date

October 2, 2019

Source

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

Recall number

Z-0361-2020

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

US Nationwide distribution in the states of GA, NY, OH, VA.

Why it was recalled

Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.

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

What was recalled

2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.