BIOMET StageOne recall
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Why was BIOMET StageOne recalled?
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
***Lot Numbers*** 860650, 215420, 555520, 583840, 089450, 283340, 132840, 413160, 058040, 181870, 408950, 409050, 409080, 851260, 234340, 338950, 581670, 201250, 518970, 024030, 030980, 166060, 219540, 219550, 219570, 429550, 296820, 296830, 296840, 296850, 298770, 041360, 041370, 041380, 146580, 146590, 443590, 844530, 115350, 251890, 326910, 630420, 870230, 389150, 572890, 698780, 970100, 199840, 481720, 398100, 398130, 789650, 789640, 877250, 202480, 202490, 398090, 398080, 398100R, 789650R, 256430, 256450, 256440, 323790, 398090R, 398130R, 630420R, 789640R, 349500, 710600, 846440, 846420, 846490, 915380, 915370, 962800, 122840, 995670, 995680, 592030, 467400, 467410, 467420, 736490, 073190, 372270, 107950, 186460, 277550. ***UDI Numbers*** (01)00880304551107(17)141007(10)860650, (01)00880304551107(17)141112(10)215420, (01)00880304551107(17)181231(10)555520, (01)00880304551107(17)181231(10)583840, (01)00880304551107(17)190206(10)089450, (01)00880304551107(17)190221(10)283340, (01)00880304551107(17)190505(10)132840, (01)00880304551107(17)190530(10)413160, (01)00880304551107(17)190725(10)058040, (01)00880304551107(17)190805(10)181870, (01)00880304551107(17)190826(10)408950, (01)00880304551107(17)190826(10)409050, (01)00880304551107(17)190826(10)409080, (01)00880304551107(17)190930(10)851260, (01)00880304551107(17)191104(10)234340, (01)00880304551107(17)191111(10)338950, (01)00880304551107(17)191209(10)581670, (01)00880304551107(17)200318(10)201250, (01)00880304551107(17)200331(10)518970, (01)00880304551107(17)200430(10)024030, (01)00880304551107(17)200501(10)030980, (01)00880304551107(17)200515(10)166060, (01)00880304551107(17)200521(10)219540, (01)00880304551107(17)200522(10)219550, (01)00880304551107(17)200522(10)219570, (01)00880304551107(17)200611(10)429550, (01)00880304551107(17)200901(10)296820, (01)00880304551107(17)200901(10)296830, (01)00880304551107(17)200901(10)296840, (01)00880304551107(17)200901(10)296850, (01)00880304551107(17)200902(10)298770, (01)00880304551107(17)201109(10)041360, (01)00880304551107(17)201110(10)041370, (01)00880304551107(17)201109(10)041380, (01)00880304551107(17)201119(10)146580, (01)00880304551107(17)201119(10)146590, (01)00880304551107(17)201218(10)443590, (01)00880304551107(17)210126(10)844530, (01)00880304551107(17)210217(10)115350, (01)00880304551107(17)210227(10)251890, (01)00880304551107(17)210307(10)326910, (01)00880304551107(17)210330(10)630420, (01)00880304551107(17)210419(10)870230, (01)00880304551107(17)210606(10)389150, (01)00880304551107(17)210622(10)572890, (01)00880304551107(17)210701(10)698780, (01)00880304551107(17)210725(10)970100, (01)00880304551107(17)210808(10)199840, (01)00880304551107(17)210908(10)481720, (01)00880304551107(17)220523(10)398100, (01)00880304551107(17)220603(10)398130, (01)00880304551107(17)220603(10)789650, (01)00880304551107(17)220611(10)789640, (01)00880304551107(17)220608(10)877250, (01)00880304551107(17)220630(10)202480, (01)00880304551107(17)220630(10)202490, (01)00880304551107(17)220823(10)398090, (01)00880304551107(17)220825(10)398080, (01)00880304551107(17)220523(10)398100R, (01)00880304551107(17)220603(10)789650R, (01)00880304551107(17)230216(10)256430, (01)00880304551107(17)230221(10)256450, (01)00880304551107(17)230228(10)256440, (01)00880304551107(17)230228(10)323790, (01)00880304551107(17)220823(10)398090R, (01)00880304551107(17)220603(10)398130R, (01)00880304551107(17)210330(10)630420R, (01)00880304551107(17)220611(10)789640R, (01)00880304551107(17)240205(10)349500, (01)00880304551107(17)240228(10)710600, (01)00880304551107(17)240306(10)846440, (01)00880304551107(17)240309(10)846420, (01)00880304551107(17)240309(10)846490, (01)00880304551107(17)240313(10)915380, (01)00880304551107(17)240314(10)915370, (01)00880304551107(17)240317(10)962800, (01)00880304551107(17)240323(10)122840, (01)00880304551107(17)240321(10)995670, (01)00880304551107(17)240321(10)995680, (01)00880304551107(17)240628(10)592030, (01)00880304551107(17)240915(10)467400, (01)00880304551107(17)240914(10)467410, (01)00880304551107(17)240913(10)467420, (01)00880304551107(17)240926(10)736490, (01)00880304551107(17)241009(10)073190, (01)00880304551107(17)241209(10)372270, (01)00880304551107(17)250116(10)107950, (01)00880304551107(17)250123(10)186460, (01)00880304551107(17)250123(10)277550
- Product
- BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
- Recalling firm
- Biomet, Inc.
- Quantity
- 230,001
- 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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.
- Recall date
- April 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)