Recall Z-1189-2007 ยท MBD Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
bioMerieux, Inc.
BacT/ALERT FN Culture Bottles, Product Number 259793
| Date | Aug 22, 2007 (initiated Feb 16, 2007) |
| Status | Terminated |
| Reason | Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles. |
| Root cause | Other |
| Action | Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand. |
| Quantity | 2,403 cases (100 bottles per case) |
| Distribution | Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992432 | BACT/ALERT FN Organon Teknika Corp., Sep 24, 1999 |