# FDA recall Z-0465-2023

> **Arthrex, Inc.** · Class II · device recall initiated 2022-11-02.

## Product

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.

## Reason for recall

The devices may be packaged with the wrong reamer size.

## Distribution

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.

## Key facts

- **Recall number:** Z-0465-2023
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-02
- **Report date:** 2022-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0465-2023

## Citation

> AI Analytics. FDA recall Z-0465-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0465-2023. Source: US FDA. Licensed CC0.

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