Recall Z-0986-2009 ยท MNI Orthosis, Spinal Pedicle Fixation
Stryker Spine
Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ. The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of
| Date | Apr 10, 2009 (initiated Sep 5, 2006) |
| Status | Terminated |
| Reason | Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down. |
| Root cause | Device Design |
| Action | A notification letter dated September 12, 2006 and a Product Accountability Form were sent via Federal Express (with return receipt) to all affected branches/agencies. Further information can be found by calling 1-201-760-8256. |
| Quantity | 2,417 units |
| Distribution | Nationwide Distribution including OR, CA, MA, VA, GA, FL, NY, NM, NJ, UT, KS, OH, MI, MN, IN, MT, TX, WI, AL, CO, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052971 | STRYKER SPINE TRIO SPINAL FIXATION SYSTEM Stryker Spine, Nov 16, 2005 |