Biomet, Inc.: BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

Is my product affected?

BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

• UPC 00880304521063

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling approximately 230,001 units of the BIOMET StageOne Hip Cement Spacer Mold with Insert (64 MM, Silicone, Sterile, Item 431185) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The product was distributed worldwide and in multiple U.S. states. The affected units are identified by specific lot numbers and UDI numbers spanning from 2015 through 2022.

The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Details from the source

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*** 004800, 104440, 734050, 082110, 912150, 961960, 092470, 630170, 602290, 357210, 508930, 474100, 913740, 364330, 396650, 295210, 854280, 952930, 816110, 362340, 184510, 988980, 988960, 827160, 362340R, 231990, 232110, 757770, 757640, 827170, 757740, 757700, 118590, 118580, 884570, 913740R, 455920, 569510, 396650R, 740650, 800090, 911390, 926010, 118580R, 911440, 911480, 925990, 926000, 926040, 868260, 911470, 926050, 464210,***UDI Numbers*** (01)00880304521063(17)151228(10)004800, (01)00880304521063(17)160728(10)104440, (01)00880304521063(17)170228(10)734050, (01)00880304521063(17)170728(10)082110, (01)00880304521063(17)170928(10)912150, (01)00880304521063(17)171207(10)961960, (01)00880304521063(17)180106(10)092470, (01)00880304521063(17)180219(10)630170, (01)00880304521063(17)180620(10)602290, (01)00880304521063(17)180904(10)357210, (01)00880304521063(17)190113(10)508930, (01)00880304521063(17)190505(10)474100, (01)00880304521063(17)191025(10)913740, (01)00880304521063(17)191215(10)364330, (01)00880304521063(17)200416(10)396650, (01)00880304521063(17)200706(10)295210, (01)00880304521063(17)200825(10)854280, (01)00880304521063(17)200825(10)952930, (01)00880304521063(17)201119(10)816110, (01)00880304521063(17)210126(10)362340, (01)00880304521063(17)210317(10)184510, (01)00880304521063(17)210919(10)988980, (01)00880304521063(17)220115(10)988960, (01)00880304521063(17)220620(10)827160, (01)00880304521063(17)210126(10)362340R, (01)00880304521063(17)220727(10)2319

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.2020-02-26
• BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.2020-02-26

All FDA (Device enforcement) recalls