SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage:
FDA device recall Z-2103-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- SpineNet
- Reason for recall
- The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
- Action taken
- SpineNET sent a Customer Notification letter dated 02/05/2013 to their only customer (Halifax Medical Center). The letter identified the affected product, problem and actions to be taken. Customers were informed to remove any copies of the original IFU-ACC-01 form from their records and replace with the IFU-ACC-02 form attached to the letter. For questions contact SpineNET office directly.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- ODP
- Quantity affected
- 400
- Distribution
- USA Nationwide Distribution in the state of Florida
- Date initiated
- 2013-02-05
- Date posted
- 2013-08-27
- Date terminated
- 2014-05-02
- Location
- Winter Park, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DAYTONA ANTERIOR CERVICAL CAGE (K110733) | Spinenet, LLC | 2011-08-25 |