Miller bone cement injector front loading cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10, sterile,
FDA device recall Z-2295-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The cartridge is brittle and at increased risk of breakage.
- Action taken
- 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
- Status
- Terminated
- Product code
- JDY
- Quantity affected
- 257 packages of 10 kits each.
- Distribution
- Nationwide, Australia, Canada, China, Colombia, Germany, India, Japan, Korea, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
- Date initiated
- 2008-06-30
- Date posted
- 2008-09-16
- Date terminated
- 2009-11-12
- Location
- Warsaw, IN
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