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U.S. Department of Health and Human Services

Class 2 Device Recall XIA 3 Polyaxial Screw

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  Class 2 Device Recall XIA 3 Polyaxial Screw see related information
Date Initiated by Firm December 30, 2009
Date Posted February 24, 2010
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-0823-2010
Recall Event ID 54271
510(K)Number K083393  
Product Classification Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease - Product Code NKB
Product Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565.
Not Sterile;
Manufactured by Stryker Spine, SA, Cestas, France.
Distributed in the USA by Stryker Spine, Allendale, NJ

Intended for use in the noncervical spine.
Code Information Lot number: A91109
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8150
Manufacturer Reason
for Recall		 The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.
FDA Determined
Cause 2		 Process control
Action Stryker Spine branches that received the recalled product were notified of the recall by an Urgent Product Recall letter, dated January 15, 2010, sent via Federal Express. The letter identified the affected product and the issue involved. It also discussed the potential hazards, risk mitigation, and the return process. Customers are to examine their inventory and hospital locations to identify the product. Customers are also to reconcile the product by utilizing the Customer Response Form and distribution sheet. In addition, they are to retrieve and return the affected product. Questions should be directed to Tiffani Rogers at 201-760-8206.
Quantity in Commerce 21
Distribution Nationwide Distribution -- IL, MO, DA, MA and CO.
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 = STRYKER SPINE
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