Home / Recalls / Arthrex, Inc. / Z-1035-2022

Z-1035-2022 Class II Terminated

Recalled by Arthrex, Inc. — Naples, FL

FDA device recall Z-1035-2022 was initiated by Arthrex, Inc. on March 25, 2022 and is designated Class II. Reason for recall: Products do not meet length and diameter specifications. The recall status is terminated (terminated May 15, 2026). Affected quantity: 300 pieces.

Recall Details

Product Type: Devices
Report Date: May 11, 2022
Initiation Date: March 25, 2022
Termination Date: May 15, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 300 pieces

Product Description

K-Wire, 1.35 mm x 170 mm

Reason for Recall

Products do not meet length and diameter specifications.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.

Code Information

Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

Other recalls by Arthrex, Inc.

Z-0465-2023 Class II — Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-898 (November 2, 2022)
Z-2107-2021 Class II — Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR (June 14, 2021)
Z-1380-2021 Class II — Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in (March 11, 2021)
Z-1310-2021 Class II — Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot (February 24, 2021)
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)
Z-0442-2019 Class II — 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular (September 13, 2018)