Arthrex Suture Washer recallZ-2918-2016 · Arthrex, Inc. · initiated Aug 12, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arthrex, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
FDA root cause category: Packaging process control
What the company is doing
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 [email protected] 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 [email protected] 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 [email protected].
Recall details
- Recall number
- Z-2918-2016
- Status
- Terminated
- Initiated by the company
- Aug 12, 2016
- Recalling firm
- Arthrex, Inc.
- Quantity
- 45 devices
- Product code
- HTN
- FDA submissions
- K043145
- Distribution
- OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Product description
Arthrex Suture Washer
Code information (models, lots, serial numbers)
Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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