Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15219 |
| Brand Name: | Ascension PyroTitan Humeral Resurfacing Arthroplasty components |
| Model: | 12 models |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | LMT Surgical 9 Business Connection 2 Kalmia Street Ellerslie Greenlane Auckland 1544 |
| Contact Information: | |
| Manufacturer: | Ascension Orthopedics Inc |
| Issue: | The manufacturer, Ascension Orthopaedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. Most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. Excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. High impact activity may cause loosening or fracture of the implant. The breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 30/8/2013 |
