Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. 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-0574-2014
- Quantity
- 922
- 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: IM71 059-01: Lot 0000 lM71059-02; IM71059-02: Lot 035M
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.
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