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Recall Observatory FDA recall evidence

Device product

4.5 BROAD SCP PLT 26-H STER

Z-2600-2017

April 28, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 77141
Status
Terminated
Classification
Class II
Quantity
87
Official record key
device-enforcement:Z-2600-2017

Official wording

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

Code information: 510K: K101073,P,K113224 Item Numbers: 47494502601

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    design verification test failures