Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mat
FDA device recall Z-0415-2018 · posted 2018-01-18 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Potentially mislabeled.
- Action taken
- Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 30
- Distribution
- Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
- Date initiated
- 2017-08-31
- Date posted
- 2018-01-18
- Date terminated
- 2019-08-06
- Location
- Gainesville, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH EQUINOXE CAGE GLENOIDS (K113309) | Exactech, Inc. | 2011-12-08 |