FDA Medical Device Recalls (openFDA)
Zimmer Inc.: 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.
- Recall number
- Z-2295-2008
- Recalling firm
- Zimmer Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2008-09-16
- Terminated
- 2009-11-12
- Reason
- The cartridge is brittle and at increased risk of breakage.
- 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
- 257 packages of 10 kits each.
- Distribution
- Nationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
- Lot, serial or model codes
- Lot 60750536.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDY
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28