Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16001 |
| Brand Name: | S&N Journey Bi-Cruciate Stabilised femoral implant |
| Model: | All models |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Smith & Nephew Surgical Ltd Unit A 36 Hillside road Wairau Valley AUCKLAND 0760 |
| Contact Information: | 0800 657 799 |
| Manufacturer: | Smith & Nephew Inc |
| Issue: | The Femoral Implant/Tibial Baseplate combination of the JOURNEY BCS Knee System has been identified in the Australian Orthopaedic Association's National Joint Replacement Registry (AOANJRR) as having a higher than expected revision rate when compared to all other primary total knee replacements.. The AOANJRR data indicates that Journey BCS has a higher incidence of revisions due to patellofemoral pain, unspecified pain and instability. The most recent JOURNEY BCS Knee System revision data published by the NJRR include: - A revision rate of 1.59 (1.34, 1.88) revisions per 100 observed component years compared to 0.72 (0.70, 0.73) for other total knee replacements; and - A yearly cumulative percent revision of 7.0% (5.8, 8.4) at 5 years compared to 3.8% (3.7, 3.8) for other total knee replacements. Smith & Nephew is withdrawing the Femoral Implant component of the JOURNEY BCS Knee System from the market. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 10/3/2014 |
