Arthrex, Inc.

The devices may be packaged with the wrong reamer size.

Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 UFRA, size 1 printed on the patient label inside the box.

The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

There is potential to break during use.

Potentially lead to anchor breakage during insertion,

There is a potential for blockage of the Hub Attachment Tube.

Products do not meet length and diameter specifications.

Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

Devices may generate excessive heat during use.

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.