| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01190-1 |
| Product Name/Description |
DePuy Synthes ATTUNE Intuition Distal Femoral Jig
Part number: 254400520 and 254400521
Multiple lot numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical Pty Ltd (JJM) has identified that the metal pin bushing was incorrectly assembled during the manufacturing process in some instruments.
JJM has also determined that if the metal pin bushing is overloaded by over tightening, there is the potential for partial or full displacement of the metal pin bushing along with fracture of the plastic around the metal pin bushing. If the plastic around the metal pin bushing fractures, there is the potential for fragments of the fractured plastic to be left in the patient. This displacement is potentially caused by excessive loading applied during pinning of the jig to the distal femoral condyles. The use of the pins in the distal resection plate is optional and the complaint rate of the bushings partially or fully displacing is 0.018%. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM staff will contact hospitals to assist with the inspection and swap of potentially affected units and informing the surgeons that jigs may continue to be used at the discretion of the medical professional following the instructions provided in the letter.
JJM is also providing surgeons with a Safety Alert notification to ensure the correct load is applied during pinning of the jig to the distal femoral condyles. This action has been closed-out on 14/07/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Pty Ltd |