# FDA recall Z-1196-2018

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

## Product

AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255	NAIL TIB DYN 08X25.5 - STERILE  800508270	NAIL TIB DYN 08X27.0 - STERILE  800508285	NAIL TIB DYN 08X28.5 - STERILE  800508300	NAIL TIB DYN 08X30.0 - STERILE  800508315	NAIL TIB DYN 08X31.5 - STERILE  800508330	NAIL TIB DYN 08X33.0 - STERILE  800508345	NAIL TIB DYN 08X34.5 - STERILE  800508360	NAIL TIB DYN 08X36.0 - STERILE  800508375	NAIL TIB DYN 08X37.5 - STERILE  800508390	NAIL TIB DYN 08X39.0 - STERILE  800508405	NAIL TIB DYN 08X40.5 - STERILE  800508420	NAIL TIB DYN 08X42.0 - STERILE  800509255	NAIL TIB DYN 09X25.5 - STERILE  800509270	NAIL TIB DYN 09X27.0 - STERILE  800509285	NAIL TIB DYN 09X28.5 - STERILE  800509300	NAIL TIB DYN 09X30.0 - STERILE  800509315	NAIL TIB DYN 09X31.5 - STERILE  800509330	NAIL TIB DYN 09X33.0 - STERILE  800509345	NAIL TIB DYN 09X34.5 - STERILE  800509360	NAIL TIB DYN 09X36.0 - STERILE  800509375	NAIL TIB DYN 09X37.5 - STERILE  800509390	NAIL TIB DYN 09X39.0 - STERILE  800509

## 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-1196-2018
- **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-1196-2018

## Citation

> AI Analytics. FDA recall Z-1196-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1196-2018. Source: US FDA. Licensed CC0.

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