| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00336-1 |
| Product Name/Description |
Natural-Knee II System with Metal-Backed Patella
Batch Numbers: 61566657, 61587666, 61681080, 61781730, 61676693, 61621642, 61487827, 61740149 & 61650259
ARTG Number: 95985 & 100318 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer received a single complaint regarding discoloration of a Natural-Knee II All Poly Congruent Tibia. An investigation into the event found that the discoloration was caused by oxidation resulting from prolonged exposure to artificial light after being machined by a third party supplier and awaiting completion and sterile packaging at Zimmer’s manufacturing facility. It is estimated that the above issue affects less than 2% of Natural-Knee II systems. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Zimmer is notifying implanting surgeons of the potential issue and the implications for implant durability. Zimmer is advising that normal post operative follow-up should be continued. For more details, please see http://www.tga.gov.au/safety/alerts-device-natural-knee-ii-system-140326.htm . |
| Contact Information |
1800 803 263 - Zimmer Customer Service |