Recall Z-2918-2016 ยท HTN Washer, Bolt Nut
Arthrex, Inc.
Arthrex Suture Washer
| Date | Aug 12, 2016 |
| Status | Terminated |
| Reason | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. |
| Root cause | Packaging process control |
| Action | 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 produc |
| Quantity | 45 devices |
| Distribution | OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043145 | BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B Arthrex, Inc., Feb 18, 2005 |