Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for
FDA device recall Z-2769-2015 · posted 2015-09-15 · Terminated
Recall details
- Recalling firm
- Applied Medical Resources Corp
- Reason for recall
- Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
- Action taken
- The firm sent out customer notification letters to International customers the beginning of July 31st, 2015 and domestic customers the week of August 3rd, 2015. The firm's letter requested customers complete the following actions: - check inventory for recalled product - complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if facility is returning or has already used any of the products - Return the confirmation form(s) to Applied Medical by emailing to recall60669166@appliedmedical.com or faxing to (949) 713-8936. - Return affected product and a copy of the confirmation form(s) to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by e-mail at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by e-mail at lcontursi@appliedmedical.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 101 units (U.S) and 38 units (International)
- Distribution
- Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
- Date initiated
- 2015-07-31
- Date posted
- 2015-09-15
- Date terminated
- 2015-11-20
- Location
- Rancho Santa Margarita, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Voyant Open Sealer-Divider Device (K143517) | Applied Medical Resources | 2015-03-27 |