Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in positi
FDA device recall Z-0573-2014 · posted 2013-12-26 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Mismarked and unmarked screws
- Action taken
- On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 993
- Distribution
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- Date initiated
- 2013-11-20
- Date posted
- 2013-12-26
- Date terminated
- 2018-09-06
- 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 |