# FDA recall Z-0768-2023

> **Acumed LLC** · Class II · device recall initiated 2022-11-29.

## Product

Acutrak 2  Part Number/Part Description:  30-0021	25.0mm Acutrak 2¿ - 5.5 Screw  30-0021-S	25.0mm Acutrak 2¿ - 5.5 Screw  30-0023	30.0mm Acutrak 2¿ - 5.5 Screw  30-0023-S	30.0mm Acutrak 2¿ - 5.5 Screw  30-0025	35.0mm Acutrak 2¿ - 5.5 Screw  30-0025-S	35.0mm Acutrak 2¿ - 5.5 Screw  30-0027	40.0mm Acutrak 2¿ - 5.5 Screw  30-0027-S	40.0mm Acutrak 2¿ - 5.5 Screw  30-0029	45.0mm Acutrak 2¿ - 5.5 Screw  30-0029-S	45.0mm Acutrak 2¿ - 5.5 Screw  30-0031	50.0mm Acutrak 2¿ - 5.5 Screw  30-0031-S	50.0mm Acutrak 2¿ - 5.5 Screw  30-0084	55.0mm Acutrak 2¿ - 5.5 Screw  30-0084-S	55.0mm Acutrak 2¿ - 5.5 Screw  30-0085	60.0mm Acutrak 2¿ - 5.5 Screw  30-0085-S	60.0mm Acutrak 2¿ - 5.5 Screw  30-0620	20.0mm Acutrak 2¿ - 4.7 Screw  30-0620-S	20.0mm Acutrak 2¿ - 4.7 Screw  30-0622	22.0mm Acutrak 2¿ - 4.7 Screw  30-0622-S	22.0mm Acutrak 2¿ - 4.7 Screw  30-0624	24.0mm Acutrak 2¿ - 4.7 Screw  30-0624-S	24.0mm Acutrak 2¿ - 4.7 Screw  30-0626	26.0mm Acutrak 2¿ - 4.7 Screw  30-0626-S	26.0mm Acutrak 2¿ - 4.7 Screw

## Reason for recall

Distribution without Pre-Market Clearance

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.

## Key facts

- **Recall number:** Z-0768-2023
- **Recalling firm:** Acumed LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-29
- **Report date:** 2023-01-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hillsboro, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0768-2023

## Citation

> AI Analytics. FDA recall Z-0768-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0768-2023. Source: US FDA. Licensed CC0.

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