FDA-Device2017-04-26Class II
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Signal Medical Corporation
Hazard
Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.
Sold states
Nationwide Distribution.
Affected count
1,640
Manufactured in
400 Pyramid Dr, N/A, Marysville, MI, United States
Products
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1834-2017Don't want to check this manually?
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