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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Reflex Hybrid variable selfdrilling screw

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  Class 2 Device Recall Stryker Reflex Hybrid variable selfdrilling screw see related information
Date Initiated by Firm June 14, 2006
Date Posted August 20, 2009
Recall Status1 Terminated 3 on August 20, 2009
Recall Number Z-1959-2009
Recall Event ID 50783
510(K)Number K040261  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
Product Stryker Reflex Hybrid variable self-drilling screw.
Non Sterile.
Manufactured by Stryker Spine SAS, Cestas, France.
Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ 07430.
Code Information All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Michele Klein
201-760-8256
Manufacturer Reason
for Recall		 Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
FDA Determined
Cause 2		 Device Design
Action Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.
Quantity in Commerce 109572 total screws, self tapping and self drilling.
Distribution Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.
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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