Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA device recall Z-0871-2026 · posted 2025-12-02 · Open, Classified
Recall details
- Recalling firm
- Paragon 28, Inc.
- 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.
- 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
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 20
- Distribution
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
- Date initiated
- 2025-10-13
- Date posted
- 2025-12-02
- Location
- Englewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Phantom Fibula Nail System (K234128) | Paragon 28, Inc. | 2024-08-22 |