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Recall Observatory FDA recall evidence

Device product

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

Z-2357-2024

June 04, 2024

Class II

Product summary

Firm
SEASPINE ORTHOPEDICS CORPORATION
Event
Event 94872
Status
Ongoing
Classification
Class II
Quantity
100 units
Official record key
device-enforcement:Z-2357-2024

Official wording

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

Code information: Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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