# FDA recall Z-0769-2023

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

## Product

AcuTwist Acutrak Compression Screws  Part Number/Part Description:  AI-0010-S	10mm AcuTwist¿ Acutrak Compression Screw  AI-0012-S	12mm AcuTwist¿ Acutrak Compression Screw  AI-0014-S	14mm AcuTwist¿ Acutrak Compression Screw  AI-0016-S	16mm AcuTwist¿ Acutrak Compression Screw  AI-0018-S	18mm AcuTwist¿ Acutrak Compression Screw  AI-0020	20mm AcuTwist¿ Acutrak Compression Screw  AI-0020-S	20mm AcuTwist¿ Acutrak Compression Screw  AI-0022-S	22mm AcuTwist¿ Acutrak Compression Screw  AI-0024-S	24mm AcuTwist¿ Acutrak Compression Screw  AI-0026	26mm AcuTwist¿ Acutrak Compression Screw  AI-0026-S	26mm AcuTwist¿ Acutrak Compression Screw  AI-0028-S	28mm AcuTwist¿ Acutrak Compression Screw  AI-0030	30mm AcuTwist¿ Acutrak Compression Screw  AI-0030-S	30mm AcuTwist¿ Acutrak Compression 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-0769-2023
- **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-0769-2023

## Citation

> AI Analytics. FDA recall Z-0769-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0769-2023. Source: US FDA. Licensed CC0.

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