Z-2918-2016 Class III Terminated
FDA device recall Z-2918-2016 was initiated by Arthrex, Inc. on August 12, 2016 and is designated Class III. Reason for recall: The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. The recall status is terminated (terminated August 20, 2019). Affected quantity: 45 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- August 12, 2016
- Termination Date
- August 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 devices
Product Description
Arthrex Suture Washer
Reason for Recall
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Distribution Pattern
OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Code Information
Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.