American Optisurgical Recalls TX1 Tissue Removal System Handpieces
American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces because they were distributed without a cleared FDA 510(k) for recent product changes.
- Product
- TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscop
- Category
- Medical Device
- Distribution
- Distributed nationwide