FDA Recall
Terminated
3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Recall: Z-0620-2012
·
Initiated August 8, 2011
Recall
- Recall Number
- Z-0620-2012
- Event Number
- 60049
- Firm
- Innovatech Medical Resources L.P.
- FEI Number
- 3009124511
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Reprocessing Controls
- Initiated
- August 8, 2011
- Posted
- January 11, 2012
- Terminated
- September 27, 2012
- Address
- 5455 Honeysuckle Road, Midlothian, TX, 76065
Description
3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Reason
Product is being removed from the field due to an over-label issue.
Action
Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066.
Distribution
Nationwide Distribution including Texas
Quantity
1 unit