Recall Z-2138-2008 ยท MVR Device, Anastomotic, Microvascular
Synovis Micro Companies Alliance Inc
GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
| Date | Aug 2, 2008 (initiated May 14, 2008) |
| Status | Terminated |
| Reason | Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. |
| Root cause | Device Design |
| Action | Urgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees. |
| Quantity | 3,812 units |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE Synovis Micro Companies Alliance, Inc., Apr 16, 2004 |