Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ 07430.
FDA Recall Z-1960-2009 · Posted 2009-08-20
Advertisement
Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeKWQ
Date Initiated2006-06-14
Date Terminated2009-08-20
Product Quantity108572 total self drilling and self tapping.
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.
Advertisement