BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***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)231990, (01)00880304521063(17)220726(10)232110, (01)00880304521063(17)221229(10)757770, (01)00880304521063(17)230116(10)757640, (01)00880304521063(17)230115(10)827170, (01)00880304521063(17)230123(10)757740, (01)00880304521063(17)230216(10)757700, (01)00880304521063(17)230417(10)118590, (01)00880304521063(17)230424(10)118580, (01)00880304521063(17)230424(10)884570, (01)00880304521063(17)191025(10)913740R, (01)00880304521063(17)240513(10)455920, (01)00880304521063(17)240528(10)569510, (01)00880304521063(17)200416(10)396650R, (01)00880304521063(17)240829(10)740650, (01)00880304521063(17)240829(10)800090, (01)00880304521063(17)240829(10)911390, (01)00880304521063(17)240828(10)926010, (01)00880304521063(17)230424(10)118580R, (01)00880304521063(17)240915(10)911440, (01)00880304521063(17)240913(10)911480, (01)00880304521063(17)240915(10)925990, (01)00880304521063(17)240913(10)926000, (01)00880304521063(17)240915(10)926040, (01)00880304521063(17)240925(10)868260, (01)00880304521063(17)240927(10)911470, (01)00880304521063(17)240926(10)926050, (01)00880304521063(17)241010(10)464210, (01)00880304521063(17)241001(10)926030 926030.
- 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 Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Product Codes/Lot Numbers:
***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)231990, (01)00880304521063(17)220726(10)232110, (01)00880304521063(17)221229(10)757770, (01)00880304521063(17)230116(10)757640, (01)00880304521063(17)230115(10)827170, (01)00880304521063(17)230123(10)757740, (01)00880304521063(17)230216(10)757700, (01)00880304521063(17)230417(10)118590, (01)00880304521063(17)230424(10)118580, (01)00880304521063(17)230424(10)884570, (01)00880304521063(17)191025(10)913740R, (01)00880304521063(17)240513(10)455920, (01)00880304521063(17)240528(10)569510, (01)00880304521063(17)200416(10)396650R, (01)00880304521063(17)240829(10)740650, (01)00880304521063(17)240829(10)800090, (01)00880304521063(17)240829(10)911390, (01)00880304521063(17)240828(10)926010, (01)00880304521063(17)230424(10)118580R, (01)00880304521063(17)240915(10)911440, (01)00880304521063(17)240913(10)911480, (01)00880304521063(17)240915(10)925990, (01)00880304521063(17)240913(10)926000, (01)00880304521063(17)240915(10)926040, (01)00880304521063(17)240925(10)868260, (01)00880304521063(17)240927(10)911470, (01)00880304521063(17)240926(10)926050, (01)00880304521063(17)241010(10)464210, (01)00880304521063(17)241001(10)926030 926030.
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1642-2020
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