# FDA recall Z-0767-2023

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

## Product

Part Number/Part Description:  30-0033-S	       30mm Acutrak¿ Fusion Device 6mm Nose    AM-0025-S	25.0mm Acutrak¿ 4/5 Bone Screw    AM-0030-S	30.0mm Acutrak¿ 4/5 Bone Screw    AM-0035-S	35.0mm Acutrak¿ 4/5 Bone Screw    AM-0040-S	40.0mm Acutrak¿ 4/5 Bone Screw    AM-0045-S	45.0mm Acutrak¿ 4/5 Bone Screw    AM-0050-S	50.0mm Acutrak¿ 4/5 Bone Screw    AP-67100-S	100mm Acutrak¿ 6/7 Fixation Screw    AP-67105-S	105mm Acutrak¿ 6/7 Fixation Screw    AP-67110-S	110mm Acutrak¿ 6/7 Fixation Screw    AP-67115-S	115mm Acutrak¿ 6/7 Fixation Screw    AP-67120-S	120mm Acutrak¿ 6/7 Fixation Screw    AP-6740-S	      40mm Acutrak¿ 6/7 Fixation Screw    AP-6745-S	      45mm Acutrak¿ 6/7 Fixation Screw    AP-6750-S	      50mm Acutrak¿ 6/7 Fixation Screw    AP-6755-S	      55mm Acutrak¿ 6/7 Fixation Screw    AP-6760-S	     60mm Acutrak¿ 6/7 Fixation Screw    AP-6765-S	     65mm Acutrak¿ 6/7 Fixation Screw    AP-6770-S	     70mm Acutrak¿ 6/7 Fixation Screw    AP-6775-S	     75mm Acutrak¿ 6/7 Fixation 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-0767-2023
- **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-0767-2023

## Citation

> AI Analytics. FDA recall Z-0767-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0767-2023. Source: US FDA. Licensed CC0.

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