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 OnPoint SCOPE PROCEDURE KIT, REF 24-3050, 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.
This recall has been terminated (originally issued December 15, 2009).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- January 9, 2009
- Posted
- December 15, 2009
- Terminated
- March 17, 2010
- Recall Number
- Z-0534-2010
- Quantity
- 56 Kits
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
BP Syringe Codes 7298534, 7334153. Kit Lot #755600, 724620, 724630, 724640, 724650, 724660, 724670, 724680, 724690, 724700, 724710, 724800, 724810, 724820, 724830, 724840, 729200, 729210, 729220, 729230, 729240, 729250, 729320, 729330, 729340, 729380, 729390, 729400, 729410, 729420, 729430, 729440, 729450, 729460, 729470, 729480, 729500, 729540, 729570, 729580, 729590, 729600, 729610, 731120, 731130, 731140, 731150, 731160, 731350, 731360, 755580, 755590, 755610, 755620, 729360, and 729370.
Root Cause
Device Design
Action Taken
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.