Recall Z-2295-2008 ยท JDY Evacuator, Vapor, Cement Monomer
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.
| Date | Sep 16, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.