Recall Z-1960-2009 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Stryker Spine
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.
| Date | Aug 20, 2009 (initiated Jun 14, 2006) |
| Status | Terminated |
| Reason | Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used. |
| Root cause | 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 | 108572 total self drilling and self tapping. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040261 | REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM Stryker Spine, Apr 16, 2004 |