Recall Z-0531-2010 ยท KDD Kit, Surgical Instrument, Disposable
Biomet Microfixation, Inc.
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 MICR
| Date | Dec 15, 2009 (initiated Jan 9, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.