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Recall Observatory FDA recall evidence

Device 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.

Z-1206-2019

January 14, 2019

Class II

Product summary

Firm
Arthrex, Inc.
Event
Event 82009
Status
Terminated
Classification
Class II
Quantity
2324
Official record key
device-enforcement:Z-1206-2019

Official wording

Reason: Devices may generate excessive heat during use.

Code information: Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices may generate excessive heat during use.