FDA recall Z-2598-2017

Zimmer Biomet, Inc. · Class II · device

Product

FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13MMDX34CM RIGHT FEM IM NAIL 14MMDX34CM RIGHT FEM IM NAIL 11MMDX36CM LEFT FEM IM NAIL 12MMDX36CM LEFT FEM IM NAIL 13MMDX36CM LEFT FEM IM NAIL 14MMDX36CM LEFT FEM IM NAIL 11MMDX36CM RIGHT FEM IM NAIL 12MMDX36CM RIGHT FEM IM NAIL 13MMDX36CM RIGHT FEM IM NAIL 14MMDX36CM RIGHT FEM IM NAIL 10MMDX38CM LEFT FEM IM NAIL 11MMDX38CM LEFT FEM IM NAIL 12MMDX38CM LEFT FEM IM NAIL 13MMDX38CM LEFT FEM IM NAIL 14MMDX38CM LEFT FEM IM NAIL 10MMDX38CM RIGHT FEM IM NAIL 11MMDX38CM RIGHT FEM IM NAIL 12MMDX38CM RIGHT FEM IM NAIL 13MMDX38CM RIGHT FEM IM NAIL 14MMDX38CM RIGHT FEM IM NAIL 10MMDX40CM LEFT FEM IM NAIL 11MMDX40CM LEFT FEM IM NAIL 12MMDX40CM LEFT FEM IM NAIL 13MMDX40CM LEFT

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-2598-2017