# FDA recall Z-1206-2019

> **Arthrex, Inc.** · Class II · device recall initiated 2019-01-14.

## Product

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.

## Reason for recall

Devices may generate excessive heat during use.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and to countries of: Germany, Brazil and Australia.

## Key facts

- **Recall number:** Z-1206-2019
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-14
- **Report date:** 2019-05-01
- **Termination date:** 2023-08-31

- **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-1206-2019

## Citation

> AI Analytics. FDA recall Z-1206-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1206-2019. Source: US FDA. Licensed CC0.

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