Recall Z-0993-2007 ยท FMF Syringe, Piston
Biomet, Inc.
Graft Preparation System, sterile, single use, disposable, Distributed by Biomet Biologics, Inc., Warsaw, Indiana; REF 800-0300.
| 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 | 46 to U.S. and international |
| Distribution | Worldwide, including USA, Chile, Italy, Spain and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021071 | PCCS GRAFT DELIVERY SYSTEM Biomet, Inc., Jul 1, 2002 |