BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 860990, 215460, 555600, 583870, 089720, 283410, 657770, 148690, 412910, 181860, 357240, 409510, 409570, 196740, 234330, 338970, 816850, 723210, 262260, 039780, 399440, 399450, 776900, 303400, 587270, 988280, 152280, 481410, 817140, 817150, 096260, 313250, 723230, 723240, 429710, 429720, 637380, 398290, 398310, 789830, 877380, 817140R, 972000, 971990, 637380R, 776900R, 809120, 583870R, 398290R, 096260R, 398310R, 915410, 914640, 914650, 963790, 962850, 995720, 995760, 153910, 153920, 277690, 277720, 277750, 484740, 723360, 197930, 736570. ***UDI Numbers*** (01)00880304551114(17)141007(10)860990, (01)00880304551114(17)141112(10)215460, (01)00880304551114(17)181202(10)555600, (01)00880304551114(17)181231(10)583870, (01)00880304551114(17)190206(10)089720, (01)00880304551114(17)190319(10)283410, (01)00880304551114(17)190327(10)657770, (01)00880304551114(17)190609(10)148690, (01)00880304551114(17)190624(10)412910, (01)00880304551114(17)190805(10)181860, (01)00880304551114(17)190819(10)357240, (01)00880304551114(17)190826(10)409510, (01)00880304551114(17)190826(10)409570, (01)00880304551114(17)191104(10)196740, (01)00880304551114(17)191103(10)234330, (01)00880304551114(17)191111(10)338970, (01)00880304551114(17)200121(10)816850, (01)00880304551114(17)200403(10)723210, (01)00880304551114(17)200522(10)262260, (01)00880304551114(17)200806(10)039780, (01)00880304551114(17)200915(10)399440, (01)00880304551114(17)200915(10)399450, (01)00880304551114(17)201019(10)776900, (01)00880304551114(17)201207(10)303400, (01)00880304551114(17)210106(10)587270, (01)00880304551114(17)210208(10)988280, (01)00880304551114(17)210224(10)152280, (01)00880304551114(17)210321(10)481410, (01)00880304551114(17)210418(10)817140, (01)00880304551114(17)210417(10)817150, (01)00880304551114(17)210506(10)096260, (01)00880304551114(17)210527(10)313250, (01)00880304551114(17)210701(10)723230, (01)00880304551114(17)210701(10)723240, (01)00880304551114(17)210831(10)429710, (01)00880304551114(17)210831(10)429720, (01)00880304551114(17)210920(10)637380, (01)00880304551114(17)220518(10)398290, (01)00880304551114(17)220518(10)398310, (01)00880304551114(17)220603(10)789830, (01)00880304551114(17)220608(10)877380, (01)00880304551114(17)210418(10)817140R, (01)00880304551114(17)220825(10)972000, (01)00880304551114(17)220906(10)971990, (01)00880304551114(17)210920(10)637380R, (01)00880304551114(17)201019(10)776900R, (01)00880304551114(17)221107(10)809120, (01)00880304551114(17)181202(10)583870R, (01)00880304551114(17)220518(10)398290R, (01)00880304551114(17)210506(10)096260R, (01)00880304551114(17)220518(10)398310R, (01)00880304551114(17)240313(10)915410, (01)00880304551114(17)240314(10)914640, (01)00880304551114(17)240314(10)914650, (01)00880304551114(17)240314(10)963790, (01)00880304551114(17)240321(10)962850, (01)00880304551114(17)240321(10)995720, (01)00880304551114(17)240321(10)995760, (01)00880304551114(17)240402(10)153910, (01)00880304551114(17)240402(10)153920, (01)00880304551114(17)240402(10)277690, (01)00880304551114(17)240402(10)277720, (01)00880304551114(17)240402(10)277750, (01)00880304551114(17)241024(10)484740, (01)00880304551114(17)241107(10)723360, (01)00880304551114(17)250113(10)197930, (01)00880304551114(17)241009(10)736570
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Biomet, Inc.
- Reason for Recall:
- Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Product Codes/Lot Numbers:
***Lot Numbers*** 860990, 215460, 555600, 583870, 089720, 283410, 657770, 148690, 412910, 181860, 357240, 409510, 409570, 196740, 234330, 338970, 816850, 723210, 262260, 039780, 399440, 399450, 776900, 303400, 587270, 988280, 152280, 481410, 817140, 817150, 096260, 313250, 723230, 723240, 429710, 429720, 637380, 398290, 398310, 789830, 877380, 817140R, 972000, 971990, 637380R, 776900R, 809120, 583870R, 398290R, 096260R, 398310R, 915410, 914640, 914650, 963790, 962850, 995720, 995760, 153910, 153920, 277690, 277720, 277750, 484740, 723360, 197930, 736570. ***UDI Numbers*** (01)00880304551114(17)141007(10)860990, (01)00880304551114(17)141112(10)215460, (01)00880304551114(17)181202(10)555600, (01)00880304551114(17)181231(10)583870, (01)00880304551114(17)190206(10)089720, (01)00880304551114(17)190319(10)283410, (01)00880304551114(17)190327(10)657770, (01)00880304551114(17)190609(10)148690, (01)00880304551114(17)190624(10)412910, (01)00880304551114(17)190805(10)181860, (01)00880304551114(17)190819(10)357240, (01)00880304551114(17)190826(10)409510, (01)00880304551114(17)190826(10)409570, (01)00880304551114(17)191104(10)196740, (01)00880304551114(17)191103(10)234330, (01)00880304551114(17)191111(10)338970, (01)00880304551114(17)200121(10)816850, (01)00880304551114(17)200403(10)723210, (01)00880304551114(17)200522(10)262260, (01)00880304551114(17)200806(10)039780, (01)00880304551114(17)200915(10)399440, (01)00880304551114(17)200915(10)399450, (01)00880304551114(17)201019(10)776900, (01)00880304551114(17)201207(10)303400, (01)00880304551114(17)210106(10)587270, (01)00880304551114(17)210208(10)988280, (01)00880304551114(17)210224(10)152280, (01)00880304551114(17)210321(10)481410, (01)00880304551114(17)210418(10)817140, (01)00880304551114(17)210417(10)817150, (01)00880304551114(17)210506(10)096260, (01)00880304551114(17)210527(10)313250, (01)00880304551114(17)210701(10)723230, (01)00880304551114(17)210701(10)723240, (01)00880304551114(17)210831(10)429710, (01)00880304551114(17)210831(10)429720, (01)00880304551114(17)210920(10)637380, (01)00880304551114(17)220518(10)398290, (01)00880304551114(17)220518(10)398310, (01)00880304551114(17)220603(10)789830, (01)00880304551114(17)220608(10)877380, (01)00880304551114(17)210418(10)817140R, (01)00880304551114(17)220825(10)972000, (01)00880304551114(17)220906(10)971990, (01)00880304551114(17)210920(10)637380R, (01)00880304551114(17)201019(10)776900R, (01)00880304551114(17)221107(10)809120, (01)00880304551114(17)181202(10)583870R, (01)00880304551114(17)220518(10)398290R, (01)00880304551114(17)210506(10)096260R, (01)00880304551114(17)220518(10)398310R, (01)00880304551114(17)240313(10)915410, (01)00880304551114(17)240314(10)914640, (01)00880304551114(17)240314(10)914650, (01)00880304551114(17)240314(10)963790, (01)00880304551114(17)240321(10)962850, (01)00880304551114(17)240321(10)995720, (01)00880304551114(17)240321(10)995760, (01)00880304551114(17)240402(10)153910, (01)00880304551114(17)240402(10)153920, (01)00880304551114(17)240402(10)277690, (01)00880304551114(17)240402(10)277720, (01)00880304551114(17)240402(10)277750, (01)00880304551114(17)241024(10)484740, (01)00880304551114(17)241107(10)723360, (01)00880304551114(17)250113(10)197930, (01)00880304551114(17)241009(10)736570
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1661-2020
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