# FDA recall Z-1111-2025

> **DDS Lab** · Class II · device recall initiated 2024-12-06.

## Product

Temporary Titanium Abutments

## Reason for recall

Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.

## Distribution

US Nationwide distribution including in the states of FL, TN, TX, MA, NH, CT, ME, WA, IN, CA, PA, NV, MO, IL, AK, MN, VT, OH, MI, VA, WI, AL, AZ, KY, MT, OK, CO, LA, GA, NY, WV, NC, NJ, MD, OR, DE, SC, ID, KS, IA, AR, NM, HI, DC, MS, NE, RI, UT.

## Key facts

- **Recall number:** Z-1111-2025
- **Recalling firm:** DDS Lab
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-06
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2025

## Citation

> AI Analytics. FDA recall Z-1111-2025. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1111-2025. Source: US FDA. Licensed CC0.

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