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U.S. Department of Health and Human Services

Class 2 Device Recall Polyaxial Pedicle Screw

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  Class 2 Device Recall Polyaxial Pedicle Screw see related information
Date Initiated by Firm January 08, 2018
Create Date February 20, 2018
Recall Status1 Terminated 3 on February 27, 2018
Recall Number Z-0644-2018
Recall Event ID 78946
510(K)Number K102248  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
Code Information Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
Recalling Firm/
Manufacturer		 Innovasis, Inc
614 E 3900 S
Salt Lake City UT 84107-1902
For Additional Information Contact Michael Thomas
801-261-2236
Manufacturer Reason
for Recall		 Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The distributors were notified of the recall on 1/8/2018 via email with an attached pdf. They are also being asked to confirm or deny the quantities showing in inventory via a Product Removal Form sent in the same email.
Quantity in Commerce 1,010 parts
Distribution United States
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 = INNOVASIS, INC.
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