# FDA recall Z-0516-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-06-12.

## Product

DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

## Reason for recall

A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture

## Distribution

AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV.  Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland

## Key facts

- **Recall number:** Z-0516-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-12
- **Report date:** 2018-02-14
- **Termination date:** 2018-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2018

## Citation

> AI Analytics. FDA recall Z-0516-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0516-2018. Source: US FDA. Licensed CC0.

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