HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) recallZ-1468-2022 · Paragon 28, Inc. · initiated May 26, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Paragon 28, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to Titanium plasma coating not present implant.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1468-2022
- Status
- Open, Classified
- Initiated by the company
- May 26, 2022
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 9 implants
- Product code
- HTY
- FDA submissions
- K171715
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Product description
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Code information (models, lots, serial numbers)
Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HammerTube™ System P40-002-0275-SParagon 28, Inc. · PIN, FIXATION, SMOOTH1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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