FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: Arthrex Suture Washer
- Recall number
- Z-2918-2016
- Recalling firm
- Arthrex, Inc.
- Product
- Arthrex Suture Washer
- Status
- Terminated
- Initiated
- 2016-08-12
- Posted
- not on file
- Terminated
- 2019-08-20
- 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 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.
- Quantity
- 45 devices
- Distribution
- OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
- Lot, serial or model codes
- Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.
- 510(k) numbers
- ["K043145"]
- PMA numbers
- not on file
- Product code
- HTN
- Firm FEI
- 1220246
- Firm city
- Naples
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28