| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00971-1 |
| Product Name/Description |
Salfo Talaris Tibial Impactor
Part Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)
Serial Numbers: 30, 152
ARTG Number: 112287 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/09/2014 |
| Responsible Entity |
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| Reason/Issue |
Complaints have been received which describe a non-optimum grip of tibial inserts with the tibial impactor Salto Talaris which could lead to the fall of the implant. Tornier's investigations have led to the conclusion that only sizes 0 and 1 of the tibial implant are not sufficiently maintained by the tibial impactor which, however, remains functional. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Tornier advised their customers that even if the impactor does not ensure optimal holding of sizes 0 and 1 only of the tibial implant, it can still safely be usedand requested that care be taken when using the device for implantation of sizes 0 and 1 of the tibial implants. Tornier is redesigning the device and will notify customers once complete. |
| Contact Information |
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