Device 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.
Z-1206-2019
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 82009
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2324
- Official record key
device-enforcement:Z-1206-2019
Official wording
Reason: Devices may generate excessive heat during use.
Code information: Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023
Distribution pattern: 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.
Derived failure modes
-
Unknown
Devices may generate excessive heat during use.