Z-1468-2022Class II

HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)

Name: Z-1468-2022 HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Creator: Paragon 28, Inc.
Published: 2022-05-26
License: https://open.fda.gov/license/

Paragon 28 / initiated 2022-05-26 / Open, Classified

FDA source

Paragon 28, Inc. began a recall of HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) on 2022-05-26. FDA classified it as Class II and gives the reason as "Due to Titanium plasma coating not present implant". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1468-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-26
Posted: 2022-07-27
Recalling firm: Paragon 28
Product: HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Product code: HTY Pin, Fixation, Smooth
Reason for recall: Due to Titanium plasma coating not present implant.
FDA root cause: Under Investigation by firm
Action: On 05/26/2022, the firm communicated via email to its customers/distributors informing them that Paragon 28 has identified via customer complaints that the titanium plasma coating is missing on the HammerTube Implants. On 06/15/2022, Paragon28 communicated an updated "URGENT Medical Device Recall" letter to customer that informed them of the potential health risks involved with the affected devices such as: " The defect may cause the implant to potentially result in reduced of pull-out force creating instability at the joint which may lead to delayed or lack of healing. " The implants, with the defect, may cause potential mating interaction failure between inserter and implant. " The defect may lead to an incorrect intended implant placement; directional and or depth. Customers are instructed to: 1. Review physical inventory, discontinue use, quarantine and not to further distribute the affected devices. 2. Return affected devices immediately to: Paragon28, Attn: Recalls 14445 Grasslands Dr. Englewood, CO 80112 Any questions, contact: Mandy Kinnee Email: [email protected] Phone: 720.966.8333 *Note: You may also contact [email protected]. 1.
Quantity in commerce: 9 implants
Distribution: U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Product codes and lots: Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1468-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1468-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-27

Product code HTY

K171715Class IIHammerTube SystemParagon 28 / cleared 2018-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)