# FDA recall Z-0959-2022

> **Acumed LLC** · Class II · device recall initiated 2022-03-09.

## Product

4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

## Reason for recall

Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm  may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, 	CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, 	OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.

## Key facts

- **Recall number:** Z-0959-2022
- **Recalling firm:** Acumed LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-03-09
- **Report date:** 2022-04-27

- **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-0959-2022

## Citation

> AI Analytics. FDA recall Z-0959-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0959-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*