Logic Fit Tibial Tamp Head

FDA device recall Z-2662-2017 · posted 2017-06-19 · Terminated

Recall details

Recalling firm

Exactech, Inc.

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.

Action taken

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

Status

Terminated

Product code

LXH

Quantity affected

573

Distribution

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, Kore

Date initiated

2017-05-25

Date posted

2017-06-19

Date terminated

2019-07-26

Location

Gainesville, FL