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Recall Observatory FDA recall evidence

Device product

Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

Z-1256-2024

December 21, 2023

Class II

Product summary

Firm
Paragon 28, Inc.
Event
Event 93900
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1256-2024

Official wording

Reason: Medical devices distributed, prior to sterilization

Code information: PA23006856

Distribution pattern: US:CA OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medical devices distributed, prior to sterilization