BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of BIOMET StageOne Hip Cement Spacer Mold (9 X 125 MM, 43 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 to numerous U.S. states. The recall involves many specific lot numbers and UDI numbers spanning from April 2019 through at least early 2021.
The source document does not specify a remedy for consumers who have this product.
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*** 964120, 668270, 595770, 400860, 854840, 867720, 867770, 386480, 539790, 700450, 930290, 215340, 457040, 615020, 588170, 588180, 963900, 963890, 737920, 805810, 036350, 527200, 527910, 976890, 977050, 977060, 239180, 239350, 680230, 914070, 436930, 586660, 718000, 996950, 152820, 447320, 583910, 489590, 688970, 983790, 237740, 600740, 804850, 281760, 610610, 251390, 640340, 858260, 328590, 712140, 712150, 238320, 430100, 753810, 953120, 816080, 816070, 227680, 647310, 057570, 057580, 759520, 759530, 656320, 787060, 107920, 107930, 737780, 115700, 737760, 737770, 754930, 754940, 754960, 754970, 754980, 202410, 202420, 520120, 520130, 520140, 520150, 754960R, 705550, 964100R, 680230R, 807460, 825790R, 027710R, 766730, 520990, 520980, 521010, 234640, 234680, 208540R, 867750R, 347510, 347520, 348000, 347990, 318490, 318510, 318530, 318540, 337310, 337330, 350230, 337340, 350220, 350240, 383530, 449960, 449970, 350210, 449950, 457040R,***UDI Numbers*** (01)00880304447165(17)190428(10)964120, (01)00880304447165(17)190528(10)668270, (01)00880304447165(17)191028(10)595770, (01)00880304447165(17)200228(10)400860, (01)00880304447165(17)200428(10)854840, (01)00880304447165(17)200728(10)867720, (01)00880304447165(17)200728(10)867770, (01)00880304447165(17)200928(10)386480, (01)00880304447165(17)201028(10)539790, (01)00880304447165(17)201028(10)700450, (01)00880304447165(17)201128(10)930290, (01)00880304447165(17)201228(10)215340, (01)00880304447165(17)210128(10)457040, (
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.