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Recall Observatory FDA recall evidence

Device product

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Z-0325-2018

July 07, 2017

Class II

Product summary

Firm
Amendia, Inc
Event
Event 77991
Status
Terminated
Classification
Class II
Quantity
41 screws
Official record key
device-enforcement:Z-0325-2018

Official wording

Reason: Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Code information: Model #85-6560-1, Lot #132117

Distribution pattern: Distribution to Georgia, USA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Incorrect labeling