Recall Z-1206-2019 ยท GFF Bur, Surgical, General & Plastic Surgery
Arthrex, Inc.
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.
| Date | Jan 14, 2019 |
| Status | Terminated |
| Reason | Devices may generate excessive heat during use. |
| Root cause | Unknown/Undetermined by firm |
| Action | On January 14, 2019, the firm, Arthrex, sent an "URGENT: VOLUNTARY PRODUCT RECALL NOTIFICATIONS" to all firms that received this device. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately discontinue use, sale, and distribution of the affected product 2. Direct customers: a) Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. Our Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b) You do not need |
| Quantity | 2324 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.