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Recall Observatory FDA recall evidence

Device product

HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

Z-1468-2022

May 26, 2022

Class II

Product summary

Firm
Paragon 28, Inc.
Event
Event 90436
Status
Ongoing
Classification
Class II
Quantity
9 implants
Official record key
device-enforcement:Z-1468-2022

Official wording

Reason: Due to Titanium plasma coating not present implant.

Code information: Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202

Distribution pattern: U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to Titanium plasma coating not present implant.