Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Recall Z-0871-2026 · Posted 2025-12-02
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Recalling FirmParagon 28, Inc.
Recall StatusOpen, Classified
Product CodeHSB
Date Initiated2025-10-13
Product Quantity20
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.
Firm Action
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 [email protected]
Complaints can be directed to [email protected]
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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