BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. has recalled approximately 230,001 units of BIOMET StageOne Shoulder Cement Spacer Mold (10 MM, 50 X 21 X 57 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The recalled products were distributed worldwide, including to numerous U.S. states. The recall affects specific lot numbers and UDI numbers identified in the official recall notice.
The recall document does not specify a remedy or recommended action for affected consumers.
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*** 860790, 215440, 381650, 555570, 089680, 283390, 509720, 657620, 132830, 372720, 097250, 281740, 409230, 409310, 409330, 196720, 196730, 338940, 452050, 581680, 776930, 386800, 233600, 079220, 204510, 262240, 429580, 595980, 849850, 849760, 041390, 041400, 041410, 041420, 041430, 245100, 245110, 245120, 245130, 779360, 915810, 115430, 152270, 326930, 441890, 665300, 924180, 009460, 169730, 389160, 424210, 723180, 723190, 743960, 199850, 970110, 390630, 732410, 398180, 398230, 398190, 398210, 398220, 789770, 789720, 789810, 877270, 202530, 789770R, 789810R, 202530R, 398190R, 674330, 674370, 809050, 325580, 916160, 916170, 916180, 916200, 219810, 398230R, 789720R, 349550, 349560, 349540, 710640, 710650, 846810, 713920, 847000, 847030, 847050, 847140, 846860, 847160, 399490, 399500, 417030, 417010, 417020, 073050, 455050, 704980, 799220, 838250, 918280, 532640, 532660, 028890, 585150, 525420,***UDI Numbers*** (01)00880304551091(17)141007(10)860790, (01)00880304551091(17)141112(10)215440, (01)00880304551091(17)181130(10)381650, (01)00880304551091(17)181231(10)555570, (01)00880304551091(17)190213(10)089680, (01)00880304551091(17)190225(10)283390, (01)00880304551091(17)190320(10)509720, (01)00880304551091(17)190331(10)657620, (01)00880304551091(17)190505(10)132830, (01)00880304551091(17)190528(10)372720, (01)00880304551091(17)190731(10)097250, (01)00880304551091(17)190818(10)281740, (01)00880304551091(17)190826(10)409230, (01)00880304551091(17)190826(10)409310, (01
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.