Arthrex, Inc. FDA Recalls

5 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulatedClass IINov 2, 2022The devices may be packaged with the wrong reamer size.	The devices may be packaged with the wrong reamer size.	Class IIDevices	Nov 2, 2022
K-Wire, 1.35 mm x 170 mmClass IIMar 25, 2022Products do not meet length and diameter specifications.	Products do not meet length and diameter specifications.	Class IIDevices	Mar 25, 2022
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCCClass IIJun 14, 2021Not properly sterilized, because the outer pouch seal on the	Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch	Class IIDevices	Jun 14, 2021
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fClass IIMar 11, 2021It was discovered that five AR-13200ST-15.0 parts were proce	It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.	Class IIDevices	Mar 11, 2021
Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.Class IIFeb 24, 2021The color indicator on the proximal end of the shaft of the	The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.	Class IIDevices	Feb 24, 2021