Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
FDA device recall Z-0603-2018 · posted 2018-01-18 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Vix Bit may fracture during use.
- Action taken
- Customers were notified on approximately 07/11/2017. Instructions included cease distribution of the affected product, notify customers if further distributed, identify and quarantine any product in inventory and complete and return the Recall Inventory Response Form. For further questions, please call (800) 392-2832.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 41 devices
- Distribution
- Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
- Date initiated
- 2017-07-11
- Date posted
- 2018-01-18
- Date terminated
- 2021-04-22
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K162567) | Blue Ortho | 2017-04-05 |