BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 230,001 units of the BIOMET StageOne Shoulder Cement Spacer Mold (14 MM, 58 X 24 X 64 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The affected product was distributed worldwide and in multiple U.S. states. The recall involves numerous lot numbers and UDI numbers spanning from October 2014 through at least 2020.
The recall notice does not specify a remedy or recommended course of action for affected consumers. Consumers who have received this product should contact Biomet, Inc. or consult their healthcare provider for guidance on next steps, as the source document does not provide specific instructions.
Written by software from the official notice below. Not reviewed by a lawyer.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Distribution: Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nev Quantity: 230,001 Lot/code info: ***Lot Numbers*** 860990, 215460, 555600, 583870, 089720, 283410, 657770, 148690, 412910, 181860, 357240, 409510, 409570, 196740, 234330, 338970, 816850, 723210, 262260, 039780, 399440, 399450, 776900, 303400, 587270, 988280, 152280, 481410, 817140, 817150, 096260, 313250, 723230, 723240, 429710, 429720, 637380, 398290, 398310, 789830, 877380, 817140R, 972000, 971990, 637380R, 776900R, 809120, 583870R, 398290R, 096260R, 398310R, 915410, 914640, 914650, 963790, 962850, 995720, 995760, 153910, 153920, 277690, 277720, 277750, 484740, 723360, 197930, 736570. ***UDI Numbers*** (01)00880304551114(17)141007(10)860990, (01)00880304551114(17)141112(10)215460, (01)00880304551114(17)181202(10)555600, (01)00880304551114(17)181231(10)583870, (01)00880304551114(17)190206(10)089720, (01)00880304551114(17)190319(10)283410, (01)00880304551114(17)190327(10)657770, (01)00880304551114(17)190609(10)148690, (01)00880304551114(17)190624(10)412910, (01)00880304551114(17)190805(10)181860, (01)00880304551114(17)190819(10)357240, (01)00880304551114(17)190826(10)409510, (01)00880304551114(17)190826(10)409570, (01)00880304551114(17)191104(10)196740, (01)00880304551114(17)191103(10)234330, (01)00880304551114(17)191111(10)338970, (01)00880304551114(17)200121(10)816850, (01)00880304551114(17)200403(10)723210, (01)00880304551114(17)200522(10)262260, (01)00880304551114(17)200806(10)039780, (01)00880304551114(17)200915(10)399440, (01)00880304551114(17)200915(10)399450, (01)00880304551114(17)201019(10)776900, (
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.