# FDA recall Z-0488-2026

> **TMJ Solutions Inc** · Class I · device recall initiated 2025-10-13.

## Product

TMJ Bilateral Implant  REF: CHG020  Sterile EO, Rx Only

## Reason for recall

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

## Distribution

US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN,  GA OUS: Canada, Spain, Brazil,

## Key facts

- **Recall number:** Z-0488-2026
- **Recalling firm:** TMJ Solutions Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-13
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ventura, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2026

## Citation

> AI Analytics. FDA recall Z-0488-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0488-2026. Source: US FDA. Licensed CC0.

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