Z-1480-2009

Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics...

Name: Z-1480-2009 Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics...
Creator: Biomet, Inc.
Published: 2009-04-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-04-09 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum... on 2009-04-09. The reason FDA records is "The package may contain two short mixing rods instead of one long and one short rod". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1480-2009
Status: Terminated
Initiated: 2009-04-09
Posted: 2009-06-30
Terminated: 2010-10-06
Recalling firm: Zimmer GmbH
Product: Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.
Product code: JDZ Mixer, Cement, For Clinical Use
Reason for recall: The package may contain two short mixing rods instead of one long and one short rod.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product. Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500.
Quantity in commerce: 250
Distribution: Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.
Product codes and lots: Lot Number: 607452.

Product code JDZ

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)