Recall Z-2918-2016
Arthrex, Inc. · initiated August 12, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Arthrex Suture Washer
Codes / lots: Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.
Reason for recall
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
FDA-determined cause: Packaging process control
Action taken
Consignees were notified 8/12/2016 of the potentially affected devices; Product/Batch Numbers: AR-7000-818T Batch #10028617. For Healthcare Professionals: immediately discontinue use of all affected products with stated numbers in their possession. Call (855) 552-5056 or email returns@arthrex.com with the product number, lot, and quantities so they may ship replacement products and expedite return of recalled product. To please complete the "Recall Acknowledgement of Receipt: postal card and return to Arthrex, Inc. Distributing Agencies: Immediately identify and hold all stated products in your inventory. Call 888-519-7255 ext. 72067 or e-mail AIM@arthrex.com Attn: Christi Zimmer. Have product number, lot number and quantities you may have so replacement product may be shipped and expedite the return of the recalled product. Please complete the "Recall Acknowledgement of Receipt" postal card and return to Arthrex. Inc. Any questions about the return of products to call 866-267-9138 and ask for Ellen Barry. Also by email to complaints@arthrez.com.
Details
- Recall number
- Z-2918-2016
- Initiated
- August 12, 2016
- Terminated
- August 20, 2019
- Product code
- HTN – Washer, Bolt Nut
- Quantity
- 45 devices
- Distribution
- OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
- Recalling firm
- Arthrex, Inc., Naples, FL