# FDA recall Z-1197-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-02-06.

## Product

AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255	NAIL TIB DYN 08 X 25.5  810508270	NAIL TIB DYN 08 X 27.0  810508285	NAIL TIB DYN 08 X 28.5  810508300	NAIL TIB DYN 08 X 30.0  810508315	NAIL TIB DYN 08 X 31.5  810508330	NAIL TIB DYN 08 X 33.0  810508345	NAIL TIB DYN 08 X 34.5  810508360	NAIL TIB DYN 08 X 36.0  810508375	NAIL TIB DYN 08 X 37.5  810508390	NAIL TIB DYN 08 X 39.0  810508405	NAIL TIB DYN 08 X 40.5  810508420	NAIL TIB DYN 08 X 42.0  810509255	NAIL TIB DYN 09 X 25.5  810509270	NAIL TIB DYN 09 X 27.0  810509285	NAIL TIB DYN 09 X 28.5  810509300	NAIL TIB DYN 09 X 30.0  810509315	NAIL TIB DYN 09 X 31.5  810509330	NAIL TIB DYN 09 X 33.0  810509345	NAIL TIB DYN 09 X 34.5  810509360	NAIL TIB DYN 09 X 36.0  810509375	NAIL TIB DYN 09 X 37.5  810509390	NAIL TIB DYN 09 X 39.0  810509405	NAIL TIB DYN 09 X 40.5  810509420	NAIL TIB DYN 09 X 42.0  810510255	NAIL TIB DYN 10 X 25.5  810510270	NAIL TIB DYN 10 X 27.0  810510285	NAIL TIB DYN 10 X 28.5  81051030

## Reason for recall

The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.

## Distribution

Worldwide and US of Indiana and country of the Republic of Korea.

## Key facts

- **Recall number:** Z-1197-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-06
- **Report date:** 2018-04-04
- **Termination date:** 2019-04-02

- **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-1197-2018

## Citation

> AI Analytics. FDA recall Z-1197-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1197-2018. Source: US FDA. Licensed CC0.

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