Recall Z-1468-2022
Paragon 28, Inc. · initiated May 26, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
Codes / lots: Part Number: P40-002-0275-S UDI-DI Code: (01)00889795033987(17)270323(10)26010822202 Lot Number: 26010822202
Reason for recall
Due to Titanium plasma coating not present implant.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1468-2022
- Initiated
- May 26, 2022
- Product code
- HTY – Pin, Fixation, Smooth
- Quantity
- 9 implants
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
- Recalling firm
- Paragon 28, Inc., Englewood, CO