Arthrex Burr Recalled for Excessive Heat Generation During Use
Arthrex, Inc. is recalling specific lots of Arthrex Oval Burr devices because they may generate excessive heat during use, posing a risk of injury to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (excessive heat generation) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Arthrex, Inc. is recalling 2,324 units of the Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT). These medical devices are indicated for the resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
The recall was initiated because the devices may generate excessive heat during use. This hazard could potentially cause thermal injury to patients during surgical procedures.
The affected units were distributed nationwide in the United States and internationally to Germany, Brazil, and Australia. The specific lot numbers involved are 10211276 (expiration date 4/30/2023) and 10202784 (expiration date 3/31/2023). Healthcare providers and patients should stop using these devices and contact Arthrex, Inc. for further instructions.
The recalled product
- 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
- Arthrex, Inc.
- Hazard
- Affected units
- 2,324
Distribution
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