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Terminated

Logic Fit Tibial Tamp Head

FDA Recall Z-2662-2017 · Posted 2017-06-19

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-05-25
Date Terminated2019-07-26
Product Quantity573

Reason for Recall

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.

Firm Action

Consignees were sent a Field Advisory Notice dated 5/22/2017 by mail informing them updated surgical techniques are available on Exactech's website (www.exac.com). The notice requested consignees: Extend the information to accounts in possession of the product Complete & return the attached Field Advisory Notice Response Form to Exactech

Root Cause

Error in labeling

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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