GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized T
FDA device recall Z-2138-2008 · posted 2008-08-02 · Terminated
Recall details
- Recalling firm
- Synovis Micro Companies Alliance Inc
- Reason for recall
- Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MVR
- Quantity affected
- 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, It
- Date initiated
- 2008-05-14
- Date posted
- 2008-08-02
- Date terminated
- 2010-04-09
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROVASCULAR ANASTOMOTIC DEVICE (K040163) | Synovis Micro Companies Alliance, Inc. | 2004-04-16 |