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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65068
Product Type Devices
Status Ongoing
Recalling Firm Custom Spine, Inc.
City Parsippany
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including Nebraska and Virginia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog Number 048545; Lot Number L363 Class II 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. 18 units Z-1819-2013