Arthrex, Inc. recalls Arthrex Suture Washer
- Recall date
- August 12, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2918-2016
- FDA classification
- Class III
- Brand / firm
- Arthrex, Inc.
- Sold / distributed
- OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Why it was recalled
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Arthrex Suture Washer
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