| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00091-1 |
| Product Name/Description |
PyroTitan Humeral Resurfacing Arthroplasty Shapers
Multiple Catalogue and Lot Numbers affected
ARTG Number: 111050 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that certain affected lots of non-conforming product may not be as sharp as intended by design.
This may be evident during use by having to increase the applied force to the shaper needed to cut and form the humeral head effectively for the placement of the implant. This increase in force can in-turn, which could create undesirable friction between the shaper and the humeral head that could potentially result in bone tissue being burned. |
| Recall Action |
Recall |
| Recall Action Instructions |
Integra LifeSciences is advising users that affected stock can be used if there are no alternatives available. Affected stock will be replaced with unaffected units. |
| Contact Information |
07 3367 6600 - Integra LifeSciences |