Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Brand
Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 is recalling HammerTube Implant, 2.75mm, 10 Cannulated (Sterile) due to Due to Titanium plasma coating not present implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to Titanium plasma coating not present implant.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026