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FDA (Device enforcement)Recalled 2024-06-04class ii

SEASPINE ORTHOPEDICS CORPORATION: Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

Hazard

Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.

Details from the source

Reason for recall: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. 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 Quantity: 100 units Lot/code info: Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

UPC codes

10889981216368

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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