Recall Z-2389-2015 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
| Date | Aug 14, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209). |
| Root cause | Labeling mix-ups |
| Action | Stryker Orthopaedics sent a recall notification via email on 5/29/2015 to their local branches. Notification letters and Product Accountability Forms were sent to Stryker branches/agencies with return receipts on 7/2/2015. |
| Quantity | 10 units |
| Distribution | OH, SC, RI, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS Stryker Orthopaedics, Aug 5, 2014 |