# FDA recall Z-2596-2017

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2017-04-28.

## Product

FEM IM NAIL 15MMDX30CM,  FEM IM NAIL 16MMDX30CM  FEM IM NAIL 14MMDX32CM  FEM IM NAIL 15MMDX32CM  FEM IM NAIL 16MMDX32CM  FEM IM NAIL 14MMDX34CM  FEM IM NAIL 15MMDX34CM  FEM IM NAIL 16MMDX34CM  FEM IM NAIL 14MMDX36CM  FEM IM NAIL 15MMDX36CM  FEM IM NAIL 14MMDX38CM  FEM IM NAIL 15MMDX38CM  FEM IM NAIL 11MMDX40CM  FEM IM NAIL 13MMDX40CM  FEM IM NAIL 14MMDX40CM  FEM IM NAIL 15MMDX40CM  FEM IM NAIL 11MMDX42CM  FEM IM NAIL 12MMDX42CM  FEM IM NAIL 13MMDX42CM  FEM IM NAIL 14MMDX42CM  FEM IM NAIL 15MMDX42CM  FEM IM NAIL 11MMDX44CM  FEM IM NAIL 12MMDX44CM  FEM IM NAIL 13MMDX44CM  FEM IM NAIL 14MMDX44CM  FEM IM NAIL 10MMDX46CM  FEM IM NAIL 11MMDX46CM  FEM IM NAIL 12MMDX46CM  FEM IM NAIL 13MMDX46CM  FEM IM NAIL 14MMDX46CM  FEM IM NAIL 10MMDX48CM  FEM IM NAIL 11MMDX48CM  FEM IM NAIL 12MMDX48CM  FEM IM NAIL 13MMDX48CM  FEM IM NAIL 14MMDX48CM  FEM IM NAIL 13MMDX50CM  FEM IM NAIL 14MMDX50CM

## Reason for recall

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

## Distribution

Domestic: Puerto Rico, AK  AL  AR  AZ  CA  CO  CT  FL  GA  HI  IA  ID  IL  IN  KS  KY  LA  MA  MD  ME  MI  MN  MO  MS  MT  NC  ND  NE  NH  NJ  NM  NV  NY  OH  OK  OR  PA  RI  SC  SD  TN  TX  UT  VA  VT  WA  WI  WV  WY    Foreign: CANADA, ALGERIA                    ARGENTINA  AUSTRALIA                  BELGIUM  BRAZIL  BRIDGEND WALES  CHINA  DUBAI UAE                  EGYPT                      EL SALVADOR                ENGLAND  ESCHBACH GERMANY  EXPORT DORAL FL  FRANCE                     GERMANY  GUATEMALA                  HONDURAS  INDIA  ITALY  JAMAICA  JAPAN  JORDAN  KOREA  LEBANON                    DELIVERY SERVICE (LYNBROOK  NY)  MALAYSIA  MEXICO  MIAMI FL  MOROCCO  NETHERLANDS                NEW ZEALAND  NICARAGUA                  PANAMA  PERU  PHARR TEXAS  POLAND  PUERTO RICO  RIO DE JANEIRO  SAUDI ARABIA               SINGAPORE  SPAIN  SWITZERLAND  TAIWAN  THAILAND  THE NETHERLANDS            TRIPOLI  UK  VIRGIN ISLANDS  VA/DOD: Both see addresses below

## Key facts

- **Recall number:** Z-2596-2017
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-28
- **Report date:** 2017-06-21
- **Termination date:** 2019-05-15

- **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-2596-2017

## Citation

> AI Analytics. FDA recall Z-2596-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2596-2017. Source: US FDA. Licensed CC0.

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