# FDA recall Z-1238-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-11-29.

## Product

Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14  A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.

## Reason for recall

Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.

## Distribution

USA (nationwide) Distribution to the states of : 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, WI., and Internationally to Japan and Netherlands.

## Key facts

- **Recall number:** Z-1238-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-29
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-05

- **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-1238-2018

## Citation

> AI Analytics. FDA recall Z-1238-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1238-2018. Source: US FDA. Licensed CC0.

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