Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
This recall has been terminated (originally issued December 26, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- November 20, 2013
- Posted
- December 26, 2013
- Terminated
- September 6, 2018
- Recall Number
- Z-0573-2014
- Quantity
- 993
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mismarked and unmarked screws
Distribution
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Lot / Code Info
Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000
Root Cause
Packaging process control
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.
More recalls by Spinefrontier, Inc.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023...
Apr 21, 2015
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion...
May 7, 2014