FDA-Device2015-06-10Class II
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Zimmer, Inc.
Hazard
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Sold states
Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
Affected count
1,689
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2015Don't want to check this manually?
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