Arthrex, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0465-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

Product Classification:

Class II

Date Initiated: November 2, 2022

Date Posted: December 14, 2022

Recall Number: Z-0465-2023

Event ID: 91143

Reason for Recall:

The devices may be packaged with the wrong reamer size.

Status: Ongoing

Product Quantity: 123 pieces

Code Information:

AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.

Distribution Pattern:

Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated