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U.S. Department of Health and Human Services

Class 2 Device Recall TMJ SYSTEM ARTHROSIMPLICITY Kit

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  Class 2 Device Recall TMJ SYSTEM ARTHROSIMPLICITY Kit see related information
Date Initiated by Firm January 09, 2009
Date Posted December 15, 2009
Recall Status1 Terminated 3 on March 17, 2010
Recall Number Z-0531-2010
Recall Event ID 53584
Product Classification Kit, Surgical Instrument, Disposable - Product Code KDD
Product BD Recalled component is labeled:

BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE.
BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com.
Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11.

Component is found in:

TMJ SYSTEM ARTHROSIMPLICITY KIT - EU REF 922075, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com

Kit contains individually packaged sterile products.

Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
Code Information BP Syringe Codes 7298534, 7334153. Kit Lot # 697060, 697090. 
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact
904-741-4400
Manufacturer Reason
for Recall		 Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by a combination of telephone, fax, e-mail and certified mail. Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.
Quantity in Commerce 2 Kits
Distribution Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
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.
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