Recall Z-1206-2019— Arthrex, Inc.
Class II · Terminated
Class II FDA medical device recall by Arthrex, Inc., initiated 2019-01-14, terminated 2023-08-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Devices may generate excessive heat during use..
- Recalling firm
- Arthrex, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-14
- Terminated
- 2023-08-31
- Firm location
- Naples, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.