R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling approximately 3,856 sterile-packaged R-F IM Nail implants in various sizes due to packaging design verification test failures. The affected implants were distributed domestically across all U.S. states and Puerto Rico, as well as internationally to multiple countries including Canada, Australia, Japan, and others. The recalled devices are identified by specific item numbers and lot codes listed in the recall notice.
The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
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: 3856 Lot/code info: 510K: K965098,K142281,K962561 Item Numbers: 00224001048 00224001142 00224001144 00224001146 00224001148 00224001246 00224001248 00224001340 00224001342 00224001344 00224001346 00224001348 00224001434 00224001436 00224001438 00224001440 00224001442 00224001444 00224001446 00224001448 Lot Numbers: 60677568 60684983 60677568R 60684983R 60670026 60670026R 60645750 60645750R 60691655 60691655R 60711471 60711471R 60715081 60715081R 60725139 60725139R 60754804 60754804R 60747476 60747462 60747462R 60747477 60815078 60815079 60816181 60815078R 60815079R 60816181R 60816180 60816180R 60820253 367186 367189 60822094 367186R 367189R 60822094R 367810 367810R 60839006 60837666 60844163 60844196 60837666R 60844163R 60844196R 367869 367871 367869R 60848701 60854080 60848701R 60854080R 60854079 60854079R 367829 367829R 60859062 368307 368310 60859063 368310R 60859063R 368299 368302 368299R 368302R 368148 368143 368294 368294R 368297 368150 368298 368301 368305 368309 368298R 368301R 368309R 368562 367809 368531 368560 368561 368577 368580 368581 367809R 368560R 368581R 368530 368578 368582 368753 368517 368306 368575 368576 368306R 368575R 60919033 60919033R 60919035 60919035R 368340 368559 368340R 368559R 60960629 60960629R 60919039 60919039R 60967107 368149 61133054 61133054R 61140815 61140815R 61140818 61140819 61140818R 61140806 61140806R 61120929 61159207 61159207R 61172912 61175878 61175879 61175878R 61175879R 61143391 61178288 61143391R 61178288R 61172908 61172906 61172907 61172907R 61
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.