Device product
Arthrex Suture Washer
Z-2918-2016
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 75050
- Status
- Terminated
- Classification
- Class III
- Quantity
- 45 devices
- Official record key
device-enforcement:Z-2918-2016
Official wording
Reason: The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Code information: Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.
Distribution pattern: OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Derived failure modes
-
Unknown
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.