FDA-Device2018-02-14Class II
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Zimmer Biomet, Inc.
Hazard
A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Sold states
AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
Affected count
1,524 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2018Don't want to check this manually?
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