Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip
FDA Recall Z-2644-2017 · Posted 2017-06-19
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-05-22
Date Terminated2019-07-26
Product Quantity477
Reason for Recall
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
Firm Action
Exactech sent an Field Advisory Notice dated May 22, 2017, by mail informing the customers the updated surgical technique is 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. For further questions, please call (800) 392-2832.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, 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 to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.