# FDA recall Z-1235-2024

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2024-01-24.

## Product

1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment  Part Number: 310.15S

## Reason for recall

Products not sterilized, sterility cannot be confirmed

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

## Key facts

- **Recall number:** Z-1235-2024
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-24
- **Report date:** 2024-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2024

## Citation

> AI Analytics. FDA recall Z-1235-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1235-2024. Source: US FDA. Licensed CC0.

---

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