Recall Z-2235-2012 ยท MNI Orthosis, Spinal Pedicle Fixation
Stryker Spine
The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distri
| Date | Aug 22, 2012 (initiated Apr 25, 2012) |
| Status | Terminated |
| Reason | The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery. |
| Root cause | Labeling mix-ups |
| Action | Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was attached for customers to complete and return via fax to 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this notice. |
| Quantity | 40 units. |
| Distribution | Distributed in Atlanta, Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062698 | TRIO + SPINAL SYSTEM Stryker Spine, Oct 11, 2006 |