Reported May 1, 2019 · Terminated
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous…
Arthrex, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers10211276 (expiration
- date4/30/2023
- and 10202784 (expiration date3/31/2023
- Amount recalled
- 2324
Where it was sold
Why it was recalled
Devices may generate excessive heat during use.
This product could cause temporary or reversible health problems — stop using it.
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