FDA-Device2018-10-10Class II

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

Exactech, Inc.
Hazard

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.

Sold states
In the countries of Australia and France
Affected count
2 units
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0012-2019

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