FDA Device recall Z-2357-2024
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Com…
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Com… by Seaspine Orthopedics, citing insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2357-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-04 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Seaspine Orthopedics |
| Distribution | AZ, CA, CO, FL, GA, IL, IN, MI, MN, MO, MT, NV, PA, SD, TN, TX, VA, WA |
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.
Identifiers
| code_info | Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Seaspine Orthopedics
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FDA Device · Class II · 2026-09-30 · Seaspine Orthopedics - SeaSpine Polyaxial Head REF Number: 41-3010
FDA Device · Class II · 2026-07-29 · Seaspine Orthopedics - Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012
FDA Device · Class II · 2025-12-24 · Seaspine Orthopedics - Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
FDA Device · Class II · 2025-09-17 · Seaspine Orthopedics - Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/…
FDA Device · Class II · 2025-01-01 · Seaspine Orthopedics
All Seaspine Orthopedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2357-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.