HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
FDA Recall Z-1468-2022 · Posted None
Recalling FirmParagon 28, Inc.
Recall StatusOpen, Classified
Product CodeHTY
Date Initiated2022-05-26
Product Quantity9 implants
Reason for Recall
Due to Titanium plasma coating not present implant.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.