FDA-Device2017-07-12Class II
Logic Fit Tibial Tamp Head
Exactech, Inc.
Hazard
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
Sold states
AL, AZ, CA, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, France, Germany, India, Italy, Japan, Korea, Luxembourg, Singapore, Spain, Switzerland, The Netherlands and United Kingdom
Affected count
573
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Logic Fit Tibial Tamp Head
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2662-2017Don't want to check this manually?
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