# FDA recall Z-0770-2023

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

## Product

Dual-Trak Clavicle Screws  Part Number/Part Description:  40-0136	3.0mm x 80mm Dual-Trak Clavicle Screw  40-0136-S	3.0mm x 80mm Dual-Trak Clavicle Screw  40-0137	3.0mm x 90mm Dual-Trak Clavicle Screw  40-0137-S	3.0mm x 90mm Dual-Trak Clavicle Screw  40-0138	3.0mm x 100mm Dual-Trak Clavicle Screw  40-0138-S	3.0mm x 100mm Dual-Trak Clavicle Screw  40-0139	3.0mm x 110mm Dual-Trak Clavicle Screw  40-0139-S	3.0mm x 110mm Dual-Trak Clavicle Screw  40-0140	3.0mm x 120mm Dual-Trak Clavicle Screw  40-0140-S	3.0mm x 120mm Dual-Trak Clavicle Screw  40-0143	3.8mm x 80mm Dual-Trak Clavicle Screw  40-0143-S	3.8mm x 80mm Dual-Trak Clavicle Screw  40-0144	3.8mm x 90mm Dual-Trak Clavicle Screw  40-0144-S	3.8mm x 90mm Dual-Trak Clavicle Screw  40-0145	3.8mm x 100mm Dual-Trak Clavicle Screw  40-0145-S	3.8mm x 100mm Dual-Trak Clavicle Screw  40-0146	3.8mm x 110mm Dual-Trak Clavicle Screw  40-0146-S	3.8mm x 110mm Dual-Trak Clavicle Screw  40-0147	3.8mm x 120mm Dual-Trak Clavicle Screw  40-0147-S	3.8mm x 12

## 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-0770-2023
- **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-0770-2023

## Citation

> AI Analytics. FDA recall Z-0770-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0770-2023. Source: US FDA. Licensed CC0.

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