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Recall Observatory FDA recall evidence

Device product

FPS 35mm x 3.5 mm non-locking screw

Z-2835-2016

July 21, 2016

Class II

Product summary

Firm
Ortho Solutions Inc
Event
Event 74849
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-2835-2016

Official wording

Reason: Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

Code information: Part number - OS326835 Lot number: 10100/269A12-68051

Distribution pattern: US Distribution

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeling