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Recall Observatory FDA recall evidence

Device product

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

Z-0012-2019

August 21, 2018

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 80996
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0012-2019

Official wording

Reason: The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

Code information: Serial Numbers: 5214432, 5214445

Distribution pattern: In the countries of Australia and France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.