BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Shoulder Cement Spacer Mold (12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The recalled products were distributed worldwide and to numerous U.S. states including Alaska, California, Florida, Texas, New York, and many others. The recall affects specific lot numbers ranging from 860910 to 186470, with corresponding UDI (Unique Device Identifier) numbers provided for identification.
The source document does not specify what consumers or healthcare facilities should do regarding this recall, including whether units should be returned, destroyed, or removed from use.
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*** 860910, 215450, 555580, 583860, 089700, 102920, 283420, 148680, 503890, 954890, 097260, 325340, 409370, 409450, 409490, 851280, 234350, 452060, 706850, 257410, 709790, 967440, 079230, 262250, 458790, 728540, 172680, 533270, 776910, 020620, 196040, 526700, 751880, 988270, 115360, 282070, 410360, 908940, 978030, 978040, 313260, 313270, 089530, 089540, 637400, 637410, 685000, 398240, 398250, 398280, 398260, 877310, 877320, 877330, 202540, 398260R, 555580R, 398240R, 674430, 809060, 747370, 916210, 916220, 262250R, 877320R, 349570, 914620, 914630, 962810, 963780, 005670, 035060, 399640, 399660, 399670, 399680, 417040, 417060, 417070, 308170, 705200, 694850, 736560, 372280, 064920, 637410R, 186470. ***UDI Numbers*** (01)00880304551008(17)141007(10)860910, (01)00880304551008(17)141112(10)215450, (01)00880304551008(17)181231(10)555580, (01)00880304551008(17)181231(10)583860, (01)00880304551008(17)190206(10)089700, (01)00880304551008(17)190215(10)102920, (01)00880304551008(17)190319(10)283420, (01)00880304551008(17)190609(10)148680, (01)00880304551008(17)190609(10)503890, (01)00880304551008(17)190721(10)954890, (01)00880304551008(17)190731(10)097260, (01)00880304551008(17)190815(10)325340, (01)00880304551008(17)190826(10)409370, (01)00880304551008(17)190826(10)409450, (01)00880304551008(17)190826(10)409490, (01)00880304551008(17)190930(10)851280, (01)00880304551008(17)191104(10)234350, (01)00880304551008(17)191119(10)452060, (01)00880304551008(17)191223(10)706850, (0
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.