# FDA recall Z-1916-2018

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2018-05-04.

## Product

Synthes Torque Limiting Handle, Part Number 03.231.013    This device is used in systems indicated for fracture fixation.

## Reason for recall

The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.

## Distribution

USA (nationwide) Distribution to the states of :  AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.

## Key facts

- **Recall number:** Z-1916-2018
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-04
- **Report date:** 2018-05-30
- **Termination date:** 2019-10-21

- **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-1916-2018

## Citation

> AI Analytics. FDA recall Z-1916-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1916-2018. Source: US FDA. Licensed CC0.

---

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