Zimmer CAS recalls Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

Recall date

April 19, 2015

Source

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

Recall number

Z-1701-2015

FDA classification

Class II

Brand / firm

Zimmer CAS

Sold / distributed

Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.

Why it was recalled

Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.

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

What was recalled

Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;