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Recall Observatory FDA recall evidence

Device product

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

Z-2688-2024

July 25, 2024

Class II

Product summary

Firm
Intrinsic Therapeutics, Inc.
Event
Event 95066
Status
Ongoing
Classification
Class II
Quantity
207 units
Official record key
device-enforcement:Z-2688-2024

Official wording

Reason: At least two units have been found to be missing a weld.

Code information: REF: BAR-IMPACTOR, P/N: 400906-A; UDI-DI: M906IMP1A0; Lot numbers: 10282203, 06152307, 08292301, 10112307.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    At least two units have been found to be missing a weld.