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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Spine ISSYS LP Inverted Screw System

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  Class 2 Device Recall Custom Spine ISSYS LP Inverted Screw System see related information
Date Initiated by Firm March 28, 2013
Date Posted July 29, 2013
Recall Status1 Terminated 3 on October 24, 2013
Recall Number Z-1819-2013
Recall Event ID 65068
510(K)Number K070281  K072866  K111099  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019

The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
Code Information Catalog Number 048545; Lot Number L363
Recalling Firm/
Manufacturer		 Custom Spine, Inc.
1140 Parsippany Blvd Ste 201
Parsippany NJ 07054-1887
For Additional Information Contact Ms. Hanaa Shahin
973-808-0019 Ext. 242
Manufacturer Reason
for Recall		 On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
FDA Determined
Cause 2		 Process control
Action Custom Spine initiated a voluntary removal On 3/28/2013, Custom Spine initiated a voluntary removal of all 10 pieces of the ISSYS LP (8.5mm X 45mm screws) Lot 363. Distributors were contacted via phone and/or email and were asked to immediately return these parts to Custom Spine.
Quantity in Commerce 18 units
Distribution Nationwide Distribution including Nebraska and Virginia.
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 = CUSTOM SPINE, INC.
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