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Smith & Nephew, Inc. recalls VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND
Recalled February 10, 2021 · FDA recall Z-0933-2021 · Smith & Nephew
Hazard
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. · FDA Class II
Units
5190 devices
Sold at
Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.
Description
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Product
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →