Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of inserti
FDA device recall Z-1957-2013 · posted 2013-08-13 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
- Action taken
- On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 9
- Distribution
- Distributed in DC and the states of MA, and OK.
- Date initiated
- 2012-05-09
- Date posted
- 2013-08-13
- Date terminated
- 2014-01-10
- 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 |