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
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is conducting a field action for certain sterile-packaged femoral intramedullary nails due to packaging design verification test failures. The recalled products include various sizes of FEM IM NAIL devices (14mm, 15mm, and 16mm diameter with 30cm, 32cm, and 34cm lengths) with a total quantity of 27,279 units. These implants were distributed domestically across all U.S. states and Puerto Rico, as well as internationally to numerous countries including Canada, Australia, Japan, Brazil, and others.
The specific item numbers and lot numbers for the affected products are detailed in the recall notice. According to the recall record, no remedy information is specified for consumers or healthcare providers regarding what action to take with the affected devices.
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: 27279 Lot/code info: Item Numbers: 00225230015 00225230016 00225232014 00225232015 00225232016 00225234014 00225234015 00225234016 00225236014 00225236015 00225238014 00225238015 00225240011 00225240013 00225240014 00225240015 00225242011 00225242012 00225242013 00225242014 00225242015 00225244011 00225244012 00225244013 00225244014 00225246010 00225246011 00225246012 00225246013 00225246014 00225248010 00225248011 00225248012 00225248013 00225248014 00225250013 00225250014 Lot Numbers: 60684923 60680624 60680627 60680627R 60680623 60680623R 60680629 60680629R 60680615 60680628 60680615R 60680628R 60680625 60680619 60680619R 60691710 60691708 60691713 60691708R 60732923 60732923R 60691711 60732925 60745751 60691711R 60745751R 60732924 60747393 60747393R 367355 60753357 367355R 60753357R 60721966 60747408 60721966R 367348 60751917 60751917R 60753355 60753356 60758098 60753355R 60715104 60758099 60735584 60735585 60735585R 367352 60789431 60789432 60789431R 367354 60747405 60797046 60797046R 60789429 60789429R 60691709 60789426 60789428 60691709R 60807362 60807365 60807366 60807376 60807376R 60807359 60817729 60817730 60817731 60817733 60817730R 60817733R 367739 367739R 367737 60817725 60817727 367737R 60817727R 60822101 60822112 60822112R 60821407 60822113 60821407R 367749 367749R 60822105 60822106 60822107 60822106R 60822107R 60822102 60822102R 60821408 60827839 60827840 60827839R 60827840R 60836675 367751 60828364 367750 367752 60836673 367750R 367766 367767 367779 367766R 60836664 60836664R 608
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.