Recall Z-1886-2009 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
Stryker Spine
Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker Spine, Allendale, NJ 07401 The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Sock
| Date | Sep 16, 2009 (initiated Jul 1, 2009) |
| Status | Terminated |
| Reason | The Trio 3.5MM Hex socket has been reported to break under high stresses. |
| Root cause | Other |
| Action | Product Correction letters were sent on July 1, 2009 to all Branches/Agencies, Surgeons and Hospital Risk Management OR Supervisor by Federal Express. The letter indicates the potential hazards associated with the breakage and it reinforces the appropriate surgical technique in using the hex socket. Customers are requested to complete an acknowledgement form and return it via FAX to Aminah Crawford at 201.760.8370 within five (5) days of receipt of the notice. If you have questions, please contact Tiffani Rogers, Regulatory Compliance Manager at 201.760.8206. |
| Quantity | 143 |
| Distribution | Nationwide - OR, AR, CA, MA, KY, MD, GA, FL, NY, NM, UT, FL, OK, KS, MI, MN, IN, MT, TX, WI, and TN. |
| FDA record | Open on fda.gov |