Recall Z-0994-2007 ยท FMF Syringe, Piston
Biomet, Inc.
Vortech Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300V. (Not sold in the United States).
| Date | Jul 4, 2007 (initiated Jun 11, 2007) |
| Status | Terminated |
| Reason | The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed. |
| Root cause | Other |
| Action | Consignees were notified by letter dated either 6/11/07 or 6/13/07 and requested to return the product. |
| Quantity | 5 to Europe |
| Distribution | Worldwide, including USA, Chile, Italy, Spain and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.