FDA-Device2016-10-12Class III

Arthrex Suture Washer

Arthrex, Inc.
Hazard

The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

Sold states
OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Affected count
45 devices
Manufactured in
1370 Creekside Blvd, N/A, Naples, FL, United States
Products
Arthrex Suture Washer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2918-2016

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