Recall archive / FDA device enforcement
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip... — FDA record Z-2357-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
- Reason
- Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
- Classification
- Class II
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Quantity
- 100 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2357-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- Jun 4, 2024
- Center classification date
- Jul 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.