CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

HammerTube Implant, 10¿ Cannulated (Sterile) recalled by Paragon 28

Paragon 28 is recalling HammerTube Implant, 10¿ Cannulated (Sterile), distributed nationwide in the US. The recall was initiated on 26 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202

Quantity recalled9 implants

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1468-2022
FDA event ID: 90436
Recalling firm: Paragon 28, Englewood, CO
Classification: Class II
Status: Ongoing
Recall initiated: 26 May 2022
FDA classified: 27 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 May 2022	Recall initiated by company
27 Jul 2022	Classified by FDA	+62 days
3 Aug 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to Titanium plasma coating not present implant.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama California Georgia Illinois Kentucky

Questions about this recall

Why was it recalled?

Due to Titanium plasma coating not present implant.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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