Class 2 Device Recall EZloc 78mm TM Femoral Fixation Femoral Hook

• Date Initiated by Firm: April 17, 2008
• Date Posted: September 04, 2008
• Recall Status: Terminated on January 13, 2012
• Recall Number: Z-1782-2008
• Recall Event ID: 47859
• 510(K)Number: K041261
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
• Code Information: Lot Number 305240
• Recalling Firm/ Manufacturer: Biomet Sports Medicine; 4861 E Airport Dr; Ontario CA 91761-7819
• For Additional Information Contact: William Coy; 909-390-0356 Ext. 136
• Manufacturer Reason for Recall: This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1
• FDA Determined Cause: Employee error
• Action: An Urgent Medical Device Removal Notice was issued by BIOMET on May 2, 2008, to all customers in the United States via overnight carrier (UPS). The U.S. Removal Notice was used as a template for all global communications regarding this urgent removal notice. Included in this recall correspondence were three Recall Letters; one for direct customers, one for Physicians and one for distributors. The notice informed customers of the problem and the risks associated with the use of this product (note: The Physician letter included more detail instruction for physician with patients already implanted with the devices). The customers were instructed to take the following actions: (1) Immediately locate, discontinue use , and quarantine the implants referenced. (2) Return the product listed in table below to Biomet Sports Medicine at the address provided. (3) Include a copy of this letter with your returned products. (4) Use priority carrier for your shipment. (5) If you have further distributed this product, you MUST notify hospital personnel of this action, via the enclosed Dear Biomet Customer notice. For questions related to this notice, an 800 number and contact person was referenced in the letter. The recalled product will be returned to the firm's warehouse and quarantined until final disposition is determined after notification to the local FDA office.
• Quantity in Commerce: 80
• Distribution: Class II Recall - Worldwide Distribution --- including USA and countries of Argentina, Chile, Italy, Netherlands, Norway & Poland.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MBI and Original Applicant = ARTHROTEK, INC.