FDAClass IIIOctober 12, 2016

Arthrex Suture Washer recall

Arthrex Suture Washer

Why was Arthrex Suture Washer recalled?

The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.

Product
Arthrex Suture Washer
Recalling firm
Arthrex, Inc.
Quantity
45 devices
Distribution
OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.
Recall date
October 12, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls