Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Produ…

Recall date
October 22, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0534-2019
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN

Why it was recalled

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

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 ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

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