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
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If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
Recall Number
Z-0871-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-13
Reported
2025-12-10
Distribution
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Code Info
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.