Home / Recalls / Arthrex, Inc. / Z-2918-2016

Z-2918-2016 Class III Terminated

Recalled by Arthrex, Inc. — Naples, FL

Recall Details

Product Type
Devices
Report Date
October 12, 2016
Initiation Date
August 12, 2016
Termination Date
August 20, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 devices

Product Description

Arthrex Suture Washer

Reason for Recall

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

Distribution Pattern

OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.

Code Information

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

Other recalls by Arthrex, Inc.

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  • Z-2733-2020 Class II — Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Pr (June 24, 2020)
  • Z-0919-2020 Class II — Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments (December 17, 2019)
  • Z-1510-2020 Class II — Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545- (October 1, 2019)
  • Z-1206-2019 Class II — Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are i (January 14, 2019)
  • Z-0724-2019 Class II — Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a (November 19, 2018)