Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes an
FDA device recall Z-1933-2013 · posted 2013-08-08 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Difficulty removing screws from the Invue caddies.
- Action taken
- SpineFrontier sent a Urgent Invue Caddy Advisory letter dated July 10, 2013, to all affected customers. Customers were advised the removal of the Invue Screw Caddy, SI70097 from the field for modification. Customers were asked to return the parts to SpineFrontier and to complete an Acknowledgement Form indicating that they have read the notice and will initiate the immediate return of the parts noted above. Please feel free to contact us at (978) 232-3990. On 8/21/2013 the recall was expanded.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSM
- Quantity affected
- 13
- Distribution
- Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
- Date initiated
- 2013-06-21
- Date posted
- 2013-08-08
- Date terminated
- 2016-01-11
- Location
- Beverly, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINE FRONTIER INDUS ACP SYSTEM (K121060) | Spinefrontier, Inc. | 2012-07-03 |