Drug recall
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product…
FDA recall event 94872 · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Event ID | 94872 |
|---|---|
| Recall numbers | Z-2357-2024 |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Product type | Devices |
| Products | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. |
| Initiation date | Jun 4, 2024 |
| Report date | Jul 24, 2024 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3012120772 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: