Recall Z-0554-2014
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
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
Codes / lots: VM 13194-34457
Reason for recall
Screw inserters may not mate properly with hex interface of the screws.
FDA-determined cause: Device Design
Action taken
The firm, SpineFrontier, Inc., sent an "Urgent PedFuse Screw Inserter Voluntary Recall Notification" letter on November 20, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to initiate the immediate return of the recalled products and to complete a recall ACKNOWLEDGEMENT FORM via fax or email to: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly MA 01915, Attn: Customer Service; Fax: 978-232-3991; email: customerservice@spinefrontier.com. Please feel free to contact at 978-232-3990 Monday thru Friday 8:30AM to 5:30PM Eastern with any questions.
Details
- Recall number
- Z-0554-2014
- Initiated
- November 20, 2013
- Posted by FDA
- December 20, 2013
- Terminated
- June 26, 2018
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Quantity
- 25
- Distribution
- US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
- Recalling firm
- SpineFrontier, Inc., Beverly, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0553-2014 Class II | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The…Screw inserters may not mate properly with hex interface of the screws. | 11/20/2013Terminated |
| Z-0555-2014 Class II | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The…Screw inserters may not mate properly with hex interface of the screws. | 11/20/2013Terminated |