PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset,
FDA device recall Z-0554-2014 · posted 2013-12-20 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Screw inserters may not mate properly with hex interface of the screws.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 25
- Distribution
- US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
- Date initiated
- 2013-11-20
- Date posted
- 2013-12-20
- Date terminated
- 2018-06-26
- Location
- Beverly, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K123164) | Spinefrontier, Inc. | 2013-02-15 |