Date Initiated by Firm | March 14, 2013 |
Date Posted | August 08, 2013 |
Recall Status1 |
Terminated 3 on June 03, 2015 |
Recall Number | Z-1926-2013 |
Recall Event ID |
64984 |
510(K)Number | K092420 |
Product Classification |
screwdriver - Product Code HXX
|
Product | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030
Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System . |
Code Information |
Lot Number: PM3979 |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
|
For Additional Information Contact | Nicole Baginski 978-232-3990 |
Manufacturer Reason for Recall | Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter. |
FDA Determined Cause 2 | Device Design |
Action | Spine Frontier sent an email dated December 10, 2012, to the affected customers that a Pedfuse Inserter with part number PM3979 needed to be returned.
Further questions please call (978) 232-3990. |
Quantity in Commerce | 8 |
Distribution | Distribution only in Texas. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = HXX
|