Intuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a surgical instrument with a functional defect (frayed or broken grip cables) that presents a risk of harm during surgical procedures. No injuries or hospitalizations have been reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 11,162 units of 8MM Tenaculum Forceps with model number 470207 and part number 470207-10. This is a Class II recall issued by the U.S. Food and Drug Administration.
The recall was initiated due to increased complaints regarding frayed or broken grip cables on the reusable surgical instruments. These cables are critical components for proper instrument operation during surgical procedures.
The recalled instruments have been distributed nationwide throughout the United States and internationally to countries including Canada, the United Kingdom, Germany, France, Japan, Australia, and many others.
Affected customers and healthcare facilities should immediately discontinue use of the recalled instruments and contact Intuitive Surgical, Inc. for further instructions regarding replacement or corrective measures.
The recalled product
- Product
- 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 11,162
Distribution
Part of a larger recall action
This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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