Z-1206-2019 Class II Terminated
FDA device recall Z-1206-2019 was initiated by Arthrex, Inc. on January 14, 2019 and is designated Class II. Reason for recall: Devices may generate excessive heat during use. The recall status is terminated (terminated August 31, 2023). Affected quantity: 2324.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- January 14, 2019
- Termination Date
- August 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2324
Product Description
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.
Reason for Recall
Devices may generate excessive heat during use.
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.
Code Information
Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023