Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Reported: July 24, 2024 Initiated: June 4, 2024 #Z-2357-2024
Product Description
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Reason for Recall
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Details
- Recalling Firm
- SEASPINE ORTHOPEDICS CORPORATION
- Units Affected
- 100 units
- 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
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No. Recalled by SEASPINE ORTHOPEDICS CORPORATION. Units affected: 100 units.
Why was this product recalled? ▼
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2357-2024.
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