Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervica
FDA device recall Z-2070-2015 · posted 2015-07-14 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Shipped to a single consignee prior to completion of final inspection.
- Action taken
- Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 4 devices.
- Distribution
- Nationwide Distribution to Florida only.
- Date initiated
- 2015-05-21
- Date posted
- 2015-07-14
- Date terminated
- 2015-07-16
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Spinal System (K142576) | Eisertech, LLC | 2015-02-26 |