Exactech, Inc. recalls Logic Fit Tibial Tamp Head

Recall date

May 25, 2017

Source

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

Recall number

Z-2662-2017

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

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

Why it was recalled

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.

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

What was recalled

Logic Fit Tibial Tamp Head