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U.S. Department of Health and Human Services

Class 3 Device Recall REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM

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  Class 3 Device Recall REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM see related information
Date Initiated by Firm August 18, 2008
Date Posted November 20, 2008
Recall Status1 Terminated 3 on June 19, 2009
Recall Number Z-0217-2009
Recall Event ID 49441
510(K)Number K040261  
Product Classification Appliance, fixation, spinal intervertebral body. - Product Code KWQ
Product Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile).
Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ.

The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation.

Code Information Lot code: NSZ.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Susan Krasny, Ph.D., RAC
201-760-8150
Manufacturer Reason
for Recall		 The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.
Quantity in Commerce 183 units
Distribution Nationwide Distribution.
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 = KWQ and Original Applicant = STRYKER SPINE
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