Arthrex, Inc. recalls Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseo

Recalled May 1, 2019 · FDA recall Z-1206-2019 · Arthrex

Hazard

Devices may generate excessive heat during use. · FDA Class II

Units

2324

Sold at

Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and to countries of: Germany, Brazil and Australia.

Description

Devices may generate excessive heat during use.

Product

Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.

Manufacturer(s)

Arthrex, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →