BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made

FDA device recall Z-0532-2010 · posted 2009-12-15 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

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

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.

Root cause

Device Design

Status

Terminated

Product code

KDD

Quantity affected

46 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, S

Date initiated

2009-01-09

Date posted

2009-12-15

Date terminated

2010-03-17

Location

Jacksonville, FL