FDA Medical Device Recalls (openFDA)
Paragon 28, Inc.: HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
- Recall number
- Z-1468-2022
- Recalling firm
- Paragon 28, Inc.
- Product
- HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
- Status
- Open, Classified
- Initiated
- 2022-05-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to Titanium plasma coating not present implant.
- 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: mkinnee@paragon28.com Phone: 720.966.8333 *Note: You may also contact complaints@paragon28.com. 1.
- Quantity
- 9 implants
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
- Lot, serial or model codes
- Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
- 510(k) numbers
- ["K171715"]
- PMA numbers
- not on file
- Product code
- HTY
- Firm FEI
- 3008650117
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28