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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 Systemsee related information
Date Initiated by FirmMarch 28, 2013
Date PostedJuly 29, 2013
Recall Status1 Terminated 3 on October 24, 2013
Recall NumberZ-1819-2013
Recall Event ID 65068
510(K)NumberK070281 K072866 K111099 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductCustom 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 ContactMs. 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
ActionCustom 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 Commerce18 units
DistributionNationwide Distribution including Nebraska and Virginia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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