Recall Z-1518-2013— American Optisurgical Inc
Class II · Terminated
Class II FDA medical device recall by American Optisurgical Inc, initiated 2013-04-30, terminated 2014-03-24. FDA's recall record names no specific 510(k) clearance for this event. 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, Laparoscopic Surgery and Plastic and Reconstructive Surgery.. Reason: American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device..
- Recalling firm
- American Optisurgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-30
- Terminated
- 2014-03-24
- Firm location
- Lake Forest, CA, United States
Product description
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, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Reason for recall
American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.