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U.S. Department of Health and Human Services

Class 2 Device Recall Sequoia Spinal System Surgical Kits

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  Class 2 Device Recall Sequoia Spinal System Surgical Kits see related information
Date Initiated by Firm February 13, 2008
Date Posted July 23, 2008
Recall Status1 Terminated 3 on July 28, 2008
Recall Number Z-1479-2008
Recall Event ID 46888
510(K)Number K072672  
Product Classification Pedicle screw spinal system - Product Code NKB
Product Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only;

The Sequoia Spinal System is designed to aid in the surgical correction of several types of spinal conditions. The product is a system of smaller devices used to provide stabilization during the development of a solid fusion mass.
Code Information Part Numbers: 3300-0001-PL and 3300-0002-PL.
Recalling Firm/
Manufacturer		 Abbott Spine
12708 Riata Vista Cir # B-100
Austin TX 78727-7167
For Additional Information Contact
512-918-2700
Manufacturer Reason
for Recall		 Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)
FDA Determined
Cause 2		 Device Design
Action The recalling firm notified sales reps regarding the recall by phone on 02/13/08. The sales reps were instructed to discontinue kit use in surgeries and to return inventory. Surgeons who had used the Sequoia System in surgery were notified of the recall via letter on 02/20/08. Surgeons were asked to monitor for post-operative dissociation in implanted patients and to notify Abbott Spine sales reps if any incidences occur.
Quantity in Commerce 38 surgical kits.
Distribution Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI.
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 = NKB and Original Applicant = ABBOTT SPINE, INC.
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