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Recall Observatory FDA recall evidence

Device product

Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Z-2580-2025

August 21, 2025

Class II

Product summary

Firm
Folsom Metal Products, Inc.
Event
Event 97480
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2580-2025

Official wording

Reason: Labeling includes shelf life that has not been validated.

Code information: All lots distributed from August 1, 2020, to July 30, 2025/UDI: 00850014548032

Distribution pattern: US Nationwide distribution in the states of AL, CA, FL, GA, IL, MD, MI, PA, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling includes shelf life that has not been validated.