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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Reflex Hybrid Screw Extractor Inner Shaft

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  Class 2 Device Recall Stryker Reflex Hybrid Screw Extractor Inner Shaft see related information
Date Initiated by Firm October 12, 2009
Date Posted April 12, 2010
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-0763-2010
Recall Event ID 54169
510(K)Number K062310  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Stryker Reflex Hybrid Screw Extractor Inner Shaft;
Not Sterile;
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ.

The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
Code Information Ref # 48511905B, all lots.
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 threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
FDA Determined
Cause 2		 Employee error
Action An "Urgent Product Recall" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370. Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.
Quantity in Commerce 983
Distribution Worldwide 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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