Recall Z-0573-2014
SpineFrontier, Inc. · initiated November 20, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
Codes / lots: Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000
Reason for recall
Mismarked and unmarked screws
FDA-determined 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.
Details
- Recall number
- Z-0573-2014
- Initiated
- November 20, 2013
- Posted by FDA
- December 26, 2013
- Terminated
- September 6, 2018
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Quantity
- 993
- Distribution
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0574-2014 Class II | Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the…Mismarked and unmarked screws | 11/20/2013Terminated |
| Z-0575-2014 Class II | Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior…Mismarked and unmarked screws | 11/20/2013Terminated |
| Z-0576-2014 Class II | Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue…Mismarked and unmarked screws | 11/20/2013Terminated |