smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
Worldwide distribution - US Nationwide distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0696-2020