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Terminated

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.

FDA Recall Z-2295-2008 · Posted 2008-09-16

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJDY
Date Initiated2008-06-30
Date Terminated2009-11-12
Product Quantity257 packages of 10 kits each.

Reason for Recall

The cartridge is brittle and at increased risk of breakage.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Nationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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