Z-2295-2008

Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY...

Name: Z-2295-2008 Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY...
Creator: Zimmer Inc.
Published: 2008-06-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-06-30 / Terminated

FDA source

Zimmer Inc. began a recall of Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile, Zimmer, Warsaw, IN; Cat. No. 5069-52... on 2008-06-30. The reason FDA records is "The cartridge is brittle and at increased risk of breakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2295-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-09-16
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile, Zimmer, Warsaw, IN; Cat. No. 5069-52. The product is used for the injection of bone cement.
Product code: JDY Evacuator, Vapor, Cement Monomer
Reason for recall: The cartridge is brittle and at increased risk of breakage.
FDA root cause: Process change control
Action: Each consignee is being notified by letter dated June 30, 2008, which will be sent via mail or email. Consignees are requested to return the product. Contact Zimmer at 1-574-372-4487 for assistance.
Quantity in commerce: 257 packages of 10 kits each.
Distribution: Nationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
Product codes and lots: Lot 60750536.

Product code JDY

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)