BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ***Lot Numbers*** 978870, 104900, 469480, 804270, 254080, 573990, 574110, 437220, 794520, 084260, 474130, 321640, 697120, 767230, 843180, 021340, 953860, 348180, 916270, 167360, 197180, 551810, 584740, 817740, 160680, 740340, 188800, 463930, 061840, 354870, 817100, 077680, 077700, 415570, 792220, 792200, 205880, 792210, 097970, 771010, 039320, 771170, 332950, 774510, 774430, 008820, 057700, 291820, 291930, 799140, 130820, 777420, 777450, 099660, 070950, 116190, 224060, 224170, 388090, 295570, 295590, 388150, 388180, 388250, 388280, 205880R, 099650, 736980, 737020, 712120, 736920, 988950, 548310, 034740, 275320, 303420, 359610, 946250, 988940, 740340R, 920850, 934760, 717470, 717510, 717530, 717540, 717550, 717560, 717570, 717590, 717440, 717480, 717490, 717520, 777640, 778140, 813850, 813870, 845500, 845510, 845520, 845530, 845540, 717460, 037570, 771010R, 084010, 037580, 152370, 717450, 326070, 717580, 580070, 772740, 788920, 788930, 777610, 789000, 807290, 807430, 807440, 807450, 029270, 055400, 580060, 807270, 807280, 807300, 807420, 883830, 807410, 792210R, 503860, 641730, 554670, 673760, 673770, 673780. ***UDI Numbers*** (01)00880304521124(17)160628(10)978870, (01)00880304521124(17)160728(10)104900, (01)00880304521124(17)161228(10)469480, (01)00880304521124(17)170228(10)804270, (01)00880304521124(17)170828(10)254080, (01)00880304521124(17)170828(10)573990, (01)00880304521124(17)170828(10)574110, (01)00880304521124(17)171028(10)437220, (01)00880304521124(17)171206(10)794520, (01)00880304521124(17)171221(10)084260, (01)00880304521124(17)180201(10)474130, (01)00880304521124(17)180211(10)321640, (01)00880304521124(17)180219(10)697120, (01)00880304521124(17)180306(10)767230, (01)00880304521124(17)180312(10)843180, (01)00880304521124(17)180329(10)021340, (01)00880304521124(17)180401(10)953860, (01)00880304521124(17)180510(10)348180, (01)00880304521124(17)180806(10)916270, (01)00880304521124(17)180831(10)167360, (01)00880304521124(17)180817(10)197180, (01)00880304521124(17)180925(10)551810, (01)00880304521124(17)190228(10)584740, (01)00880304521124(17)190513(10)817740, (01)00880304521124(17)190822(10)160680, (01)00880304521124(17)191024(10)740340, (01)00880304521124(17)191202(10)188800, (01)00880304521124(17)200112(10)463930, (01)00880304521124(17)200218(10)061840, (01)00880304521124(17)200410(10)354870, (01)00880304521124(17)200513(10)817100, (01)00880304521124(17)200609(10)077680, (01)00880304521124(17)200609(10)077700, (01)00880304521124(17)200710(10)415570, (01)00880304521124(17)200811(10)792220, (01)00880304521124(17)200901(10)792200, (01)00880304521124(17)200921(10)205880, (01)00880304521124(17)201001(10)792210, (01)00880304521124(17)201111(10)097970, (01)00880304521124(17)201112(10)771010, (01)00880304521124(17)201112(10)039320, (01)00880304521124(17)201112(10)771170, (01)00880304521124(17)210204(10)332950, (01)00880304521124(17)210215(10)774510, (01)00880304521124(17)210219(10)774430, (01)00880304521124(17)210318(10)008820, (01)00880304521124(17)210406(10)057700, (01)00880304521124(17)210615(10)291820, (01)00880304521124(17)210615(10)291930, (01)00880304521124(17)210830(10)799140, (01)00880304521124(17)210831(10)130820, (01)00880304521124(17)220329(10)777420, (01)00880304521124(17)220329(10)777450, (01)00880304521124(17)220725(10)099660, (01)00880304521124(17)221230(10)070950, (01)00880304521124(17)221207(10)116190, (01)00880304521124(17)221231(10)224060, (01)00880304521124(17)230123(10)224170, (01)00880304521124(17)230125(10)388090, (01)00880304521124(17)230125(10)295570, (01)00880304521124(17)230127(10)295590, (01)00880304521124(17)230125(10)388150, (01)00880304521124(17)230129(10)388180, (01)00880304521124(17)230131(10)388250, (01)00880304521124(17)230125(10)388280, (01)00880304521124(17)200921(10)205880R, (01)00880304521124(17)230223(10)099650, (01)00880304521124(17)230301(10)736980, (01)00880304521124(17)230306(10)737020, (01)00880304521124(17)230313(10)712120, (01)00880304521124(17)230307(10)736920, (01)00880304521124(17)230314(10)988950, (01)00880304521124(17)230321(10)548310, (01)00880304521124(17)230321(10)034740, (01)00880304521124(17)230412(10)275320, (01)00880304521124(17)230413(10)303420, (01)00880304521124(17)230412(10)359610, (01)00880304521124(17)221207(10)946250, (01)00880304521124(17)230417(10)988940, (01)00880304521124(17)191024(10)740340R, (01)00880304521124(17)230507(10)920850, (01)00880304521124(17)230510(10)934760, (01)00880304521124(17)240527(10)717470, (01)00880304521124(17)240527(10)717510, (01)00880304521124(17)240525(10)717530, (01)00880304521124(17)240524(10)717540, (01)00880304521124(17)240523(10)717550, (01)00880304521124(17)240525(10)717560, (01)00880304521124(17)240527(10)717570, (01)00880304521124(17)240524(10)717590, (01)00880304521124(17)240527(10)717440, (01)00880304521124(17)240618(10)717480, (01)00880304521124(17)240529(10)717490, (01)00880304521124(17)240528(10)717520, (01)00880304521124(17)240617(10)777640, (01)00880304521124(17)240612(10)778140, (01)00880304521124(17)240614(10)813850, (01)00880304521124(17)240612(10)813870, (01)00880304521124(17)240623(10)845500, (01)00880304521124(17)240616(10)845510, (01)00880304521124(17)240617(10)845520, (01)00880304521124(17)240617(10)845530, (01)00880304521124(17)240802(10)845540, (01)00880304521124(17)240810(10)717460, (01)00880304521124(17)240819(10)037570, (01)00880304521124(17)201112(10)771010R, (01)00880304521124(17)240819(10)084010, (01)00880304521124(17)240828(10)037580, (01)00880304521124(17)240830(10)152370, (01)00880304521124(17)240825(10)717450, (01)00880304521124(17)240912(10)326070, (01)00880304521124(17)240917(10)717580, (01)00880304521124(17)240927(10)580070, (01)00880304521124(17)240926(10)772740, (01)00880304521124(17)240926(10)788920, (01)00880304521124(17)240925(10)788930, (01)00880304521124(17)241004(10)777610, (01)00880304521124(17)241002(10)789000, (01)00880304521124(17)241009(10)807290, (01)00880304521124(17)241003(10)807430, (01)00880304521124(17)241003(10)807440, (01)00880304521124(17)241003(10)807450, (01)00880304521124(17)241011(10)029270, (01)00880304521124(17)241011(10)055400, (01)00880304521124(17)241011(10)580060, (01)00880304521124(17)241011(10)807270, (01)00880304521124(17)241011(10)807280, (01)00880304521124(17)241011(10)807300, (01)00880304521124(17)241011(10)807420, (01)00880304521124(17)241010(10)883830, (01)00880304521124(17)241105(10)807410, (01)00880304521124(17)201001(10)792210R, (01)00880304521124(17)241120(10)503860, (01)00880304521124(17)241119(10)641730, (01)00880304521124(17)241119(10)554670, (01)00880304521124(17)241211(10)673760, (01)00880304521124(17)241205(10)673770, (01)00880304521124(17)241205(10)673780
- 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 Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Product Codes/Lot Numbers:
***Lot Numbers*** 978870, 104900, 469480, 804270, 254080, 573990, 574110, 437220, 794520, 084260, 474130, 321640, 697120, 767230, 843180, 021340, 953860, 348180, 916270, 167360, 197180, 551810, 584740, 817740, 160680, 740340, 188800, 463930, 061840, 354870, 817100, 077680, 077700, 415570, 792220, 792200, 205880, 792210, 097970, 771010, 039320, 771170, 332950, 774510, 774430, 008820, 057700, 291820, 291930, 799140, 130820, 777420, 777450, 099660, 070950, 116190, 224060, 224170, 388090, 295570, 295590, 388150, 388180, 388250, 388280, 205880R, 099650, 736980, 737020, 712120, 736920, 988950, 548310, 034740, 275320, 303420, 359610, 946250, 988940, 740340R, 920850, 934760, 717470, 717510, 717530, 717540, 717550, 717560, 717570, 717590, 717440, 717480, 717490, 717520, 777640, 778140, 813850, 813870, 845500, 845510, 845520, 845530, 845540, 717460, 037570, 771010R, 084010, 037580, 152370, 717450, 326070, 717580, 580070, 772740, 788920, 788930, 777610, 789000, 807290, 807430, 807440, 807450, 029270, 055400, 580060, 807270, 807280, 807300, 807420, 883830, 807410, 792210R, 503860, 641730, 554670, 673760, 673770, 673780. ***UDI Numbers*** (01)00880304521124(17)160628(10)978870, (01)00880304521124(17)160728(10)104900, (01)00880304521124(17)161228(10)469480, (01)00880304521124(17)170228(10)804270, (01)00880304521124(17)170828(10)254080, (01)00880304521124(17)170828(10)573990, (01)00880304521124(17)170828(10)574110, (01)00880304521124(17)171028(10)437220, (01)00880304521124(17)171206(10)794520, (01)00880304521124(17)171221(10)084260, (01)00880304521124(17)180201(10)474130, (01)00880304521124(17)180211(10)321640, (01)00880304521124(17)180219(10)697120, (01)00880304521124(17)180306(10)767230, (01)00880304521124(17)180312(10)843180, (01)00880304521124(17)180329(10)021340, (01)00880304521124(17)180401(10)953860, (01)00880304521124(17)180510(10)348180, (01)00880304521124(17)180806(10)916270, (01)00880304521124(17)180831(10)167360, (01)00880304521124(17)180817(10)197180, (01)00880304521124(17)180925(10)551810, (01)00880304521124(17)190228(10)584740, (01)00880304521124(17)190513(10)817740, (01)00880304521124(17)190822(10)160680, (01)00880304521124(17)191024(10)740340, (01)00880304521124(17)191202(10)188800, (01)00880304521124(17)200112(10)463930, (01)00880304521124(17)200218(10)061840, (01)00880304521124(17)200410(10)354870, (01)00880304521124(17)200513(10)817100, (01)00880304521124(17)200609(10)077680, (01)00880304521124(17)200609(10)077700, (01)00880304521124(17)200710(10)415570, (01)00880304521124(17)200811(10)792220, (01)00880304521124(17)200901(10)792200, (01)00880304521124(17)200921(10)205880, (01)00880304521124(17)201001(10)792210, (01)00880304521124(17)201111(10)097970, (01)00880304521124(17)201112(10)771010, (01)00880304521124(17)201112(10)039320, (01)00880304521124(17)201112(10)771170, (01)00880304521124(17)210204(10)332950, (01)00880304521124(17)210215(10)774510, (01)00880304521124(17)210219(10)774430, (01)00880304521124(17)210318(10)008820, (01)00880304521124(17)210406(10)057700, (01)00880304521124(17)210615(10)291820, (01)00880304521124(17)210615(10)291930, (01)00880304521124(17)210830(10)799140, (01)00880304521124(17)210831(10)130820, (01)00880304521124(17)220329(10)777420, (01)00880304521124(17)220329(10)777450, (01)00880304521124(17)220725(10)099660, (01)00880304521124(17)221230(10)070950, (01)00880304521124(17)221207(10)116190, (01)00880304521124(17)221231(10)224060, (01)00880304521124(17)230123(10)224170, (01)00880304521124(17)230125(10)388090, (01)00880304521124(17)230125(10)295570, (01)00880304521124(17)230127(10)295590, (01)00880304521124(17)230125(10)388150, (01)00880304521124(17)230129(10)388180, (01)00880304521124(17)230131(10)388250, (01)00880304521124(17)230125(10)388280, (01)00880304521124(17)200921(10)205880R, (01)00880304521124(17)230223(10)099650, (01)00880304521124(17)230301(10)736980, (01)00880304521124(17)230306(10)737020, (01)00880304521124(17)230313(10)712120, (01)00880304521124(17)230307(10)736920, (01)00880304521124(17)230314(10)988950, (01)00880304521124(17)230321(10)548310, (01)00880304521124(17)230321(10)034740, (01)00880304521124(17)230412(10)275320, (01)00880304521124(17)230413(10)303420, (01)00880304521124(17)230412(10)359610, (01)00880304521124(17)221207(10)946250, (01)00880304521124(17)230417(10)988940, (01)00880304521124(17)191024(10)740340R, (01)00880304521124(17)230507(10)920850, (01)00880304521124(17)230510(10)934760, (01)00880304521124(17)240527(10)717470, (01)00880304521124(17)240527(10)717510, (01)00880304521124(17)240525(10)717530, (01)00880304521124(17)240524(10)717540, (01)00880304521124(17)240523(10)717550, (01)00880304521124(17)240525(10)717560, (01)00880304521124(17)240527(10)717570, (01)00880304521124(17)240524(10)717590, (01)00880304521124(17)240527(10)717440, (01)00880304521124(17)240618(10)717480, (01)00880304521124(17)240529(10)717490, (01)00880304521124(17)240528(10)717520, (01)00880304521124(17)240617(10)777640, (01)00880304521124(17)240612(10)778140, (01)00880304521124(17)240614(10)813850, (01)00880304521124(17)240612(10)813870, (01)00880304521124(17)240623(10)845500, (01)00880304521124(17)240616(10)845510, (01)00880304521124(17)240617(10)845520, (01)00880304521124(17)240617(10)845530, (01)00880304521124(17)240802(10)845540, (01)00880304521124(17)240810(10)717460, (01)00880304521124(17)240819(10)037570, (01)00880304521124(17)201112(10)771010R, (01)00880304521124(17)240819(10)084010, (01)00880304521124(17)240828(10)037580, (01)00880304521124(17)240830(10)152370, (01)00880304521124(17)240825(10)717450, (01)00880304521124(17)240912(10)326070, (01)00880304521124(17)240917(10)717580, (01)00880304521124(17)240927(10)580070, (01)00880304521124(17)240926(10)772740, (01)00880304521124(17)240926(10)788920, (01)00880304521124(17)240925(10)788930, (01)00880304521124(17)241004(10)777610, (01)00880304521124(17)241002(10)789000, (01)00880304521124(17)241009(10)807290, (01)00880304521124(17)241003(10)807430, (01)00880304521124(17)241003(10)807440, (01)00880304521124(17)241003(10)807450, (01)00880304521124(17)241011(10)029270, (01)00880304521124(17)241011(10)055400, (01)00880304521124(17)241011(10)580060, (01)00880304521124(17)241011(10)807270, (01)00880304521124(17)241011(10)807280, (01)00880304521124(17)241011(10)807300, (01)00880304521124(17)241011(10)807420, (01)00880304521124(17)241010(10)883830, (01)00880304521124(17)241105(10)807410, (01)00880304521124(17)201001(10)792210R, (01)00880304521124(17)241120(10)503860, (01)00880304521124(17)241119(10)641730, (01)00880304521124(17)241119(10)554670, (01)00880304521124(17)241211(10)673760, (01)00880304521124(17)241205(10)673770, (01)00880304521124(17)241205(10)673780
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1648-2020
Related Recalls
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Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.