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U.S. Department of Health and Human Services

Class 2 Device Recall Screw inserter (screwdriver orthopedic manual surgical instrument)

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  Class 2 Device Recall Screw inserter (screwdriver orthopedic manual surgical instrument) see related information
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 and Original Applicant = SPINEFRONTIER, INC.
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