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 13M
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling approximately 24,969 sterile-packaged femoral intramedullary nails in various sizes due to packaging design verification test failures. The affected products were distributed domestically across all U.S. states and Puerto Rico, as well as internationally to Canada and numerous other countries including Australia, Brazil, China, France, Germany, India, Italy, Japan, and Korea. The recalled items are identified by specific item numbers and lot numbers listed in the recall notice.
The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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 Quantity: 24969 Lot/code info: 510K: K965098,K032367 Item Numbers: 00225730004 00225730014 00225732003 00225732004 00225732013 00225732014 00225734001 00225734003 00225734004 00225734011 00225734013 00225734014 00225736001 00225736002 00225736003 00225736004 00225736011 00225736012 00225736013 00225736014 00225738000 00225738001 00225738002 00225738003 00225738004 00225738010 00225738011 00225738012 00225738013 00225738014 00225740000 00225740001 00225740002 00225740003 00225740004 00225740010 00225740011 00225740012 00225740013 00225740014 00225742000 00225742001 00225742002 00225742003 00225742004 00225742010 00225742011 00225742012 00225742013 00225742014 00225744000 00225744001 00225744002 00225744003 00225744004 00225744010 00225744011 00225744012 00225744013 00225744014 00225746000 00225746001 00225746002 00225746003 00225746004 00225746010 00225746011 00225746012 00225746013 00225746014 00225748000 00225748001 00225748002 00225748003 00225748010 00225748011 00225748012 00225748013 00225750000 00225750001 00225750002 00225750003 00225750010 00225750011 00225750012 00225750013 Lot Numbers: 60667034 60667034R 60668410 60668410R 60598252 60654244 60671255 60654244R 60671255R 60654236 60684926 60684999 60654236R 60684926R 60684999R 60629337 60629337R 60691903 60691928 60691934 60691903R 60691928R 60691934R 60695640 60684996 60684996R 60671256 60671258 60691915 60695638 60671256R 60671258R 60691915R 60695638R 60691893 60691901 60691909 60691911 60695628 60691901R 60691909R 60691911R 60695628R 367281 36729
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.