# FDA recall Z-2107-2023

> **Osteomed, LLC** · Class II · device recall initiated 2023-05-31.

## Product

REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

## Reason for recall

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.

## Key facts

- **Recall number:** Z-2107-2023
- **Recalling firm:** Osteomed, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-31
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Addison, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2023

## Citation

> AI Analytics. FDA recall Z-2107-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2107-2023. Source: US FDA. Licensed CC0.

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