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Recall Observatory FDA recall evidence

Device product

Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)

Z-1875-2018

March 20, 2018

Class II

Product summary

Firm
Epic Extremity, LLC
Event
Event 79824
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1875-2018

Official wording

Reason: There is an error in the caddy artwork that misidentifies a specific plate and screw.

Code information: Catalog Number: 2111-1010 Lot: 51461

Distribution pattern: The products were distributed to the following US states: FL, PA, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is an error in the caddy artwork that misidentifies a specific plate and screw.