TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TI
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling 1,499 tibial intramedullary nails in various sizes due to packaging design verification test failures. The sterile-packaged implants were distributed domestically across all U.S. states and Puerto Rico, as well as internationally to multiple countries including Canada, Australia, France, Germany, Japan, and others. The affected products are identified by specific item numbers and lot codes listed in the recall notice.
The recall affects implants that may not maintain their sterility due to the packaging defect. The source document 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: 1499 Lot/code info: Item Numbers: 00225326015 00225328015 00225330015 00225332014 00225332015 00225334014 00225334015 00225336014 00225336015 00225338014 00225338015 00225340013 00225340014 00225340015 00225342013 00225342014 00225342015 00225344011 00225344013 00225344014 00225346011 00225346012 00225346013 Lot Codes: 60689046 60689046R 60689048 60689048R 60541593 60541593R 60708943 60708943R 60733116 60733116R 60718442 60738224 60738224R 60747428 60541594 60759282 60759282R 60729914 60748950 60748950R 60750986 60750986R 60753362 60753362R 60837656 60837656R 60837650 60837657 60837657R 60837655 367894 60848473 367894R 60848473R 368331 60848488 60848488R 368105 368327 368105R 368327R 60848481 60848484 60848481R 60848484R 60858220 368330 368330R 368235 368395 60858225 368235R 368395R 60858225R 368428 368433 368403 368415 368422 368442 368403R 368415R 368422R 368442R 368394 368409 368410 368421 368429 368434 368437 368438 368439 368440 368441 60848485 368394R 368409R 368439R 368440R 368441R 60848485R 60858223 60933764 60973733 60973733R 60976652 60973738 60985622 60985622R 60985623 60985623R 60985624 60985625 60985625R 61040177 61040177R 61040179 60984603 61003748 61048029 61003748R 61040178 369111 61079864 61079864R 369093 369104 369116 369115 369113 369181 60973739 60973739R 61143370 61143370R 61188445 61170168 61170168R 61172763 61172763R 61187613 61187613R 61184356 61187623 61184356R 61187623R 61194163 61244786 61244786R 61277990 61277990R 61263725 61263726 61263725R 61267999 61277985 61277986
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.