Z-2600-2017 Class II Terminated
FDA device recall Z-2600-2017 was initiated by Zimmer Biomet, Inc. on April 28, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 15, 2019). Affected quantity: 87.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- April 28, 2017
- Termination Date
- May 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87
Product Description
Reason for Recall
Distribution Pattern
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