Recall Z-0871-2026
Paragon 28, Inc. · initiated October 13, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Codes / lots: UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Reason for recall
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
FDA-determined cause: Device Design
Action taken
On 10/13/2025, recall notices were emailed to distributors who were asked to do the following: 1) Return affected devices to the firm using return label. 2) Ensure that in instances where you have distributed this affected product, that you forward this Recall Notification to your customers. 3) Replacements are available by contacting Orders@paragon28.com Complaints can be directed to complaints@paragon28.com
Details
- Recall number
- Z-0871-2026
- Initiated
- October 13, 2025
- Posted by FDA
- December 2, 2025
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 20
- Distribution
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
- Recalling firm
- Paragon 28, Inc., Englewood, CO