# FDA recall Z-1808-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-08-07.

## Product

Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302     For use during orthopaedic surgery for implantation of a prosthesis.

## Reason for recall

There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.

## Key facts

- **Recall number:** Z-1808-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2018-05-23
- **Termination date:** 2018-08-23

- **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-1808-2018

## Citation

> AI Analytics. FDA recall Z-1808-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1808-2018. Source: US FDA. Licensed CC0.

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