# FDA recall Z-1224-2018

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

## Product

PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

## Reason for recall

A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.

## Distribution

Non-USA Customer

## Key facts

- **Recall number:** Z-1224-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-12
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-09

- **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-1224-2018

## Citation

> AI Analytics. FDA recall Z-1224-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1224-2018. Source: US FDA. Licensed CC0.

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