FDA-Device2020-08-05Class II

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

Arthrex, Inc.
Hazard

Screws provided in packaging are 5mm shorter than intended

Sold states
International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Affected count
28 units
Manufactured in
1370 Creekside Blvd, N/A, Naples, FL, United States
Products
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2733-2020

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