The Recall Desk
HighFDA (Devices)·Z-1206-2019·Announced 2019-05-01

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.

What this means for you

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.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
2,324

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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