FDA-Device2021-02-10Class II
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.
Smith & Nephew, Inc.
Hazard
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Sold states
Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.
Affected count
5190 devices
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2021Don't want to check this manually?
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