medical MODERATE Updated 2019-05-01

Arthrex, Inc. recalls Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT)

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Recalled 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.

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Hazard / Issue

Devices may generate excessive heat during use.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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