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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NKB
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