Arthrex Suture Washer
FDA Recall Z-2918-2016 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeHTN
Date Initiated2016-08-12
Date Terminated2019-08-20
Product Quantity45 devices
Reason for Recall
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Firm 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].
Root Cause
Packaging process control
Distribution Pattern
OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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