HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Recall
- Recall Number
- Z-1468-2022
- Event Number
- 90436
- Firm
- Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062
- FEI Number
- 3008650117
- Product Code
- HTY
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 26, 2022
Description
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Due to Titanium plasma coating not present implant.
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.
U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
9 implants