Device product
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Z-2357-2024
Product summary
- Event
- Event 94872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-2357-2024
Official wording
Reason: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Code information: Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
Distribution pattern: The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona
Derived failure modes
-
Unknown
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.