Curved Needle Driver recall
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci…
Why was Curved Needle Driver recalled?
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model numbers: 428088-12, 428088-13; all lots
- Product
- Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 3698 total units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
- Recall date
- September 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)