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Recall Observatory FDA recall evidence

Device product

INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

Z-1835-2017

February 22, 2017

Class II

Product summary

Firm
Ace Surgical Supply Co., Inc.
Event
Event 76604
Status
Terminated
Classification
Class II
Quantity
87
Official record key
device-enforcement:Z-1835-2017

Official wording

Reason: Incorrect device was packaged.

Code information: Lot Number: 16100050

Distribution pattern: Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect device was packaged.