BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 104420, 982400, 982410, 321650, 321010, 623250, 922960, 031220, 997610, 556620, 122900, 382940, 419310, 474090, 758580, 009860, 913730, 188870, 640320, 790260, 132370, 820480, 931920, 952920, 627850, 816100, 990340, 152520, 334530, 362320, 362330, 966960, 829830, 322800, 322790, 322810, 322810R, 827140, 362330R, 229620, 757600, 808680, 118530, 118540, 972010, 757500, 757510, 808690, 827120, 827150, 118520, 118560, 884560, 827900, 827870, 431600, 884550, 455990, 479080, 569440, 479070, 479090, 479100, 569390, 569400, 569410, 569420, 569450, 569490, 827120R, 884550R, 455980, 985690, 986830, 990920, 990000, 987900, 990680, 978380. ***UDI Numbers*** (01)00880304521056(17)160928(10)104420, (01)00880304521056(17)171228(10)982400, (01)00880304521056(17)171221(10)982410, (01)00880304521056(17)180122(10)321650, (01)00880304521056(17)180208(10)321010, (01)00880304521056(17)180308(10)623250, (01)00880304521056(17)180313(10)922960, (01)00880304521056(17)180329(10)031220, (01)00880304521056(17)180329(10)997610, (01)00880304521056(17)180617(10)556620, (01)00880304521056(17)180819(10)122900, (01)00880304521056(17)190106(10)382940, (01)00880304521056(17)190113(10)419310, (01)00880304521056(17)190425(10)474090, (01)00880304521056(17)190425(10)758580, (01)00880304521056(17)190819(10)009860, (01)00880304521056(17)191024(10)913730, (01)00880304521056(17)191125(10)188870, (01)00880304521056(17)200124(10)640320, (01)00880304521056(17)200512(10)790260, (01)00880304521056(17)200610(10)132370, (01)00880304521056(17)200813(10)820480, (01)00880304521056(17)200827(10)931920, (01)00880304521056(17)200903(10)952920, (01)00880304521056(17)201106(10)627850, (01)00880304521056(17)201110(10)816100, (01)00880304521056(17)201204(10)990340, (01)00880304521056(17)210112(10)152520, (01)00880304521056(17)210111(10)334530, (01)00880304521056(17)210209(10)362320, (01)00880304521056(17)210209(10)362330, (01)00880304521056(17)210303(10)966960, (01)00880304521056(17)210524(10)829830, (01)00880304521056(17)210921(10)322800, (01)00880304521056(17)210927(10)322790, (01)00880304521056(17)220107(10)322810, (01)00880304521056(17)220107(10)322810R, (01)00880304521056(17)220621(10)827140, (01)00880304521056(17)210209(10)362330R, (01)00880304521056(17)220726(10)229620, (01)00880304521056(17)230120(10)757600, (01)00880304521056(17)230124(10)808680, (01)00880304521056(17)230209(10)118530, (01)00880304521056(17)230209(10)118540, (01)00880304521056(17)230209(10)972010, (01)00880304521056(17)230216(10)757500, (01)00880304521056(17)230216(10)757510, (01)00880304521056(17)230217(10)808690, (01)00880304521056(17)230219(10)827120, (01)00880304521056(17)230217(10)827150, (01)00880304521056(17)230302(10)118520, (01)00880304521056(17)230302(10)118560, (01)00880304521056(17)230301(10)884560, (01)00880304521056(17)230308(10)827900, (01)00880304521056(17)230417(10)827870, (01)00880304521056(17)230425(10)431600, (01)00880304521056(17)230425(10)884550, (01)00880304521056(17)240513(10)455990, (01)00880304521056(17)240517(10)479080, (01)00880304521056(17)240608(10)569440, (01)00880304521056(17)240614(10)479070, (01)00880304521056(17)240615(10)479090, (01)00880304521056(17)240620(10)479100, (01)00880304521056(17)240610(10)569390, (01)00880304521056(17)240614(10)569400, (01)00880304521056(17)240612(10)569410, (01)00880304521056(17)240609(10)569420, (01)00880304521056(17)240614(10)569450, (01)00880304521056(17)240614(10)569490, (01)00880304521056(17)230219(10)827120R, (01)00880304521056(17)230425(10)884550R, (01)00880304521056(17)240830(10)455980, (01)00880304521056(17)240925(10)985690, (01)00880304521056(17)240926(10)986830, (01)00880304521056(17)240925(10)990920, (01)00880304521056(17)241003(10)990000, (01)00880304521056(17)241011(10)987900, (01)00880304521056(17)241024(10)990680, (01)00880304521056(17)250102(10)978380
- 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, 60 MM, Silicone, Sterile, Item 431184.
Product Codes/Lot Numbers:
***Lot Numbers*** 104420, 982400, 982410, 321650, 321010, 623250, 922960, 031220, 997610, 556620, 122900, 382940, 419310, 474090, 758580, 009860, 913730, 188870, 640320, 790260, 132370, 820480, 931920, 952920, 627850, 816100, 990340, 152520, 334530, 362320, 362330, 966960, 829830, 322800, 322790, 322810, 322810R, 827140, 362330R, 229620, 757600, 808680, 118530, 118540, 972010, 757500, 757510, 808690, 827120, 827150, 118520, 118560, 884560, 827900, 827870, 431600, 884550, 455990, 479080, 569440, 479070, 479090, 479100, 569390, 569400, 569410, 569420, 569450, 569490, 827120R, 884550R, 455980, 985690, 986830, 990920, 990000, 987900, 990680, 978380. ***UDI Numbers*** (01)00880304521056(17)160928(10)104420, (01)00880304521056(17)171228(10)982400, (01)00880304521056(17)171221(10)982410, (01)00880304521056(17)180122(10)321650, (01)00880304521056(17)180208(10)321010, (01)00880304521056(17)180308(10)623250, (01)00880304521056(17)180313(10)922960, (01)00880304521056(17)180329(10)031220, (01)00880304521056(17)180329(10)997610, (01)00880304521056(17)180617(10)556620, (01)00880304521056(17)180819(10)122900, (01)00880304521056(17)190106(10)382940, (01)00880304521056(17)190113(10)419310, (01)00880304521056(17)190425(10)474090, (01)00880304521056(17)190425(10)758580, (01)00880304521056(17)190819(10)009860, (01)00880304521056(17)191024(10)913730, (01)00880304521056(17)191125(10)188870, (01)00880304521056(17)200124(10)640320, (01)00880304521056(17)200512(10)790260, (01)00880304521056(17)200610(10)132370, (01)00880304521056(17)200813(10)820480, (01)00880304521056(17)200827(10)931920, (01)00880304521056(17)200903(10)952920, (01)00880304521056(17)201106(10)627850, (01)00880304521056(17)201110(10)816100, (01)00880304521056(17)201204(10)990340, (01)00880304521056(17)210112(10)152520, (01)00880304521056(17)210111(10)334530, (01)00880304521056(17)210209(10)362320, (01)00880304521056(17)210209(10)362330, (01)00880304521056(17)210303(10)966960, (01)00880304521056(17)210524(10)829830, (01)00880304521056(17)210921(10)322800, (01)00880304521056(17)210927(10)322790, (01)00880304521056(17)220107(10)322810, (01)00880304521056(17)220107(10)322810R, (01)00880304521056(17)220621(10)827140, (01)00880304521056(17)210209(10)362330R, (01)00880304521056(17)220726(10)229620, (01)00880304521056(17)230120(10)757600, (01)00880304521056(17)230124(10)808680, (01)00880304521056(17)230209(10)118530, (01)00880304521056(17)230209(10)118540, (01)00880304521056(17)230209(10)972010, (01)00880304521056(17)230216(10)757500, (01)00880304521056(17)230216(10)757510, (01)00880304521056(17)230217(10)808690, (01)00880304521056(17)230219(10)827120, (01)00880304521056(17)230217(10)827150, (01)00880304521056(17)230302(10)118520, (01)00880304521056(17)230302(10)118560, (01)00880304521056(17)230301(10)884560, (01)00880304521056(17)230308(10)827900, (01)00880304521056(17)230417(10)827870, (01)00880304521056(17)230425(10)431600, (01)00880304521056(17)230425(10)884550, (01)00880304521056(17)240513(10)455990, (01)00880304521056(17)240517(10)479080, (01)00880304521056(17)240608(10)569440, (01)00880304521056(17)240614(10)479070, (01)00880304521056(17)240615(10)479090, (01)00880304521056(17)240620(10)479100, (01)00880304521056(17)240610(10)569390, (01)00880304521056(17)240614(10)569400, (01)00880304521056(17)240612(10)569410, (01)00880304521056(17)240609(10)569420, (01)00880304521056(17)240614(10)569450, (01)00880304521056(17)240614(10)569490, (01)00880304521056(17)230219(10)827120R, (01)00880304521056(17)230425(10)884550R, (01)00880304521056(17)240830(10)455980, (01)00880304521056(17)240925(10)985690, (01)00880304521056(17)240926(10)986830, (01)00880304521056(17)240925(10)990920, (01)00880304521056(17)241003(10)990000, (01)00880304521056(17)241011(10)987900, (01)00880304521056(17)241024(10)990680, (01)00880304521056(17)250102(10)978380
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1641-2020
Related Recalls
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