Medical device recalls Moderate risk

Zimmer, Inc. recalls Zimmer Guide Wires for orthopedic procedures.

Recall date
August 27, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2820-2015
FDA classification
Class II
Brand / firm
Zimmer, Inc.
Sold / distributed
Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia,…

Why it was recalled

Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.

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

What was recalled

Zimmer Guide Wires for orthopedic procedures.

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