Z-0530-2010

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

Name: Z-0530-2010 BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ...
Creator: Biomet Microfixation, Inc.
Published: 2009-01-09
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2009-01-09 / Terminated / root cause: design

FDA source

Biomet Microfixation, Inc. began a recall of 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... on 2009-01-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0530-2010
Status: Terminated
Initiated: 2009-01-09
Posted: 2009-12-15
Terminated: 2010-03-17
Recalling firm: Biomet Microfixation
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 REF 922070, 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.
Product code: KDD Kit, Surgical Instrument, Disposable
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
Root cause tag: design
FDA 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 in commerce: 121 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.
Product codes and lots: BP Syringe Codes 7298534, 7334153. Kit Lot #: 1107001, 1107002, 539500, 542870 542880 543090, 554890, 554900, 554920, 554930, 554940, 554950, 554970, 554980, 554990, 555000, 555010, 555020, 555030, 557720, 557730, 557750, 557790, 557800, 557810, 557820, 557830, 560540, 560550, 560560, 577500, 577510, 577520, 577530, 577560, 577590, 577600, 577610, 577620, 577630, 577640, 577650, 577660, 577680, 577690, 637110, 637120, 661250, 661270, 662960, 666880, 667830, 667850, 685230, 685240, 685250, 685260, 685770, 685780, 685790, 685800, 685810, 685820, 554870, 554880, 554910, 554960, 557780, 577540, 577550, 577570, 577580, 637130, 685760, and 698200.

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)