Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Recall Initiated
- October 13, 2025
- Posted
- December 2, 2025
- Recall Number
- Z-0871-2026
- Quantity
- 20
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.
Distribution
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Lot / Code Info
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Root 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