# FDA recall Z-0287-2019

> **Zimmer Biomet, Inc.** · Class I · device recall initiated 2018-02-19.

## Product

SpF  PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator      SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

## Reason for recall

Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

## Distribution

US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country  of:  Australia.

## Key facts

- **Recall number:** Z-0287-2019
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-19
- **Report date:** 2018-11-07
- **Termination date:** 2020-08-25

- **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-0287-2019

## Citation

> AI Analytics. FDA recall Z-0287-2019. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0287-2019. Source: US FDA. Licensed CC0.

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