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Paragon 28, Inc. Recall 90436

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

Paragon 28, Inc. Recall 90436 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1468-2022
Event ID90436
Event DescriptionHammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Quantity9 implants
Recall ReasonDue to Titanium plasma coating not present implant.
Device Classification20220803
Device Code InfoPart Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
Center Classification Date20220727
Recall Initiation Date20220526
Recalling FirmParagon 28, Inc.
Initial Notification Letter
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