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.
FDA Recall Z-1959-2009 · Posted 2009-08-20
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Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeKWQ
Date Initiated2006-06-14
Date Terminated2009-08-20
Product Quantity109572 total screws, self tapping and self drilling.
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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