Device product
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Z-0849-2025
Product summary
- Event
- Event 95938
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,603
- Official record key
device-enforcement:Z-0849-2025
Official wording
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Code information: Model Number: 470006 Part Number: 470006-12 UDI-DI code: 00886874112151 Batch Numbers: K10230120 K10230118 K12230119 K11230118 K10230217 Part Number: 470006-13 UDI-DI code: 00886874112151 Batch Numbers: K10230623 K10240506 K10240815
Distribution pattern: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam
Derived failure modes
-
Unknown
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.