Soft Face No Bounce Mallet /Catalog: BIO recalled over foreign material

Recall date

February 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Signal Medical Corporation recalls Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

Recall number

Z-1834-2017

FDA classification

Class II

Brand / firm

Signal Medical Corporation

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

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

What was recalled

Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090