| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00320-1 |
| Product Name/Description |
LP rotate, sizes 25-27 cat.1-6.
Model number: E443296
Product numbers LRP062, LRF062, LRPU62, and LRFU62.
Manufacturing Lot Number: HF141022
ARTG Number: 141148 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Ossur is recalling the product due to a defect discovered during assembly (Outer tube threads not machined correctly in the CNC process). The threads of the outer tube of the shock module of LP Rotate were too short, resulting in insecure assembly to the foot blade. Use of the product may cause the patient to fall, as the shock module can become loose from the foot blade.The user may also hear noise coming from the foot module. The failure could possibly be noticed by users as they will feel looseness on ankle foot device. If use is continued, connection of shock adapter to foot blade might break and user may fall.
This recall action was undertaken prior to notifying TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Ossur is replacing all the affected devices with the unaffected units.In case the customers are wearing a faulty product, Ossur is recommending scheduling a visit to have the product replaced with a new LP Rotate that is currently available. |
| Contact Information |
02 8838 2800 - Customer Service |