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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech 1.5" Novation Calcar Planer Guide Tip

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  Class 2 Device Recall Exactech 1.5" Novation Calcar Planer Guide Tip see related information
Date Initiated by Firm May 22, 2017
Date Posted June 19, 2017
Recall Status1 Open3, Classified
Recall Number Z-2644-2017
Recall Event ID 77002
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product 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
Code Information Catalog #: 161-30-00 with the manufacturing lots #'s 38878-001, 38878-002, 49777-001, 51825-005, 51825-006, 52224-007, 51825-006, 52224-005, 52224-006, 57167-001, 59775-003, 62580-004, 66464-003, 66464-004, 70720-001, 71530-001, 73477-002, 75153-001, and 74999-001.
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
800-392-2832
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by 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.
Quantity in Commerce 477
Distribution 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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