Z-2918-2016Class III

Arthrex Suture Washer

Name: Z-2918-2016 Arthrex Suture Washer
Creator: Arthrex, Inc.
Published: 2016-08-12
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2016-08-12 / Terminated / root cause: packaging

FDA source

Arthrex, Inc. began a recall of Arthrex Suture Washer on 2016-08-12. FDA classified it as Class III and gives the reason as "The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2918-2016
Classification: Class III
Status: Terminated
Initiated: 2016-08-12
Posted: 2016-09-30
Terminated: 2019-08-20
Recalling firm: Arthrex GmbH
Product: Arthrex Suture Washer
Product code: HTN Washer, Bolt Nut
Reason for recall: The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Root cause tag: packaging
FDA 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 [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].
Quantity in commerce: 45 devices
Distribution: OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Product codes and lots: Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2918-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2918-2016	Class III	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30

Product code HTN

K043145Class IIBi-Cortical Bio-Post and Washer, Model Ar-1367BArthrex, Inc. / cleared 2005-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)