FDA recall Z-2596-2017

Zimmer Biomet, Inc. · Class II · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2596-2017