BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling the BIOMET StageOne Hip Cement Spacer Mold (13 X 145 MM, 57 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Approximately 230,001 units have been distributed worldwide, including distribution to all U.S. states. The recall affects numerous lot numbers, which are identified in the recall record with specific lot codes and UDI numbers.
The recall record does not specify a remedy or corrective 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*** 027900, 670510, 371230, 836660, 602430, 008340, 008360, 008380, 162240, 162250, 700500, 186490, 377390, 658100, 658110, 658120, 658130, 473170, 912530, 086110, 571910, 230030, 230050, 658620, 658640, 170090, 170070, 527210, 527930, 600440, 600500, 239200, 239400, 680240, 729290, 844520, 978070, 260560, 413060, 747280, 845740, 996980, 215490, 381730, 447360, 627970, 868840, 070900, 339490, 600720, 771050, 182020, 325410, 610630, 745470, 251400, 557660, 847720, 858270, 157440, 328640, 628360, 628430, 790270, 238740, 514580, 679770, 953140, 197720, 336630, 152540, 527470, 647360, 945690, 057590, 229330, 759540, 949860, 258720, 332610, 787070, 595080, 595090, 737830, 737840, 737850, 755150, 755160, 755170, 737860, 755120, 755130, 755140, 757300, 202130, 202460, 733920R, 733910R, 732040, 118130, 416640R, 141060, 141040, 378370, 378390, 765990, 766020, 766030, 766050, 766060, 043910, 921310, 766080, 234700, 234710, 473170R, 350740, 350940, 658620R, 347850, 347840, 347980, 347830, 157440R, 318670, 337700, 318660, 318680, 318690, 318860, 337580, 337650, 337660, 350360, 350370, 350390, 350540, 350560, 318850, 337460, 337500, 350380, 350550, 383600, 383610, 383630, 337470, 070900R,***UDI Numbers*** (01)00880304447172(17)190128(10)027900, (01)00880304447172(17)190628(10)670510, (01)00880304447172(17)200128(10)371230, (01)00880304447172(17)200428(10)836660, (01)00880304447172(17)200628(10)602430, (01)00880304447172(17)200828(10)008340, (01)00880304447172(17)200801(10)00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.