FDAFDA · Alimentos y medicamentos·N.º oficial Z-1652-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Publicado el 15 de abril de 2020 · Inicio del retiro: 26 de febrero de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Biomet, Inc.
- Distribuidor
- 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.
- Lote
- ***Lot Numbers*** 288190, 288210, 580430, 612120, 574610, 521820, 736490, 406850, 767250, 348190, 265750, 851110, 549350, 266450, 301440, 188860, 464070, 994620, 701410, 939800, 112710, 119970, 375010, 661210, 661220, 205950, 596580, 774500, 997550, 145740, 291880, 799200, 397020, 552570, 799200R, 552570R, 070340, 708360, 708380, 708350, 810080, 225020, 618510, 737390, 618520, 388640, 487350, 737370, 737400, 275390, 950440, 548650, 708400, 848360, 596580R, 487350R,***UDI Numbers*** (01)00880304521162(17)160828(10)288190, (01)00880304521162(17)160828(10)288210, (01)00880304521162(17)170128(10)580430, (01)00880304521162(17)170528(10)612120, (01)00880304521162(17)170828(10)574610, (01)00880304521162(17)171101(10)521820, (01)00880304521162(17)180115(10)736490, (01)00880304521162(17)180121(10)406850, (01)00880304521162(17)180301(10)767250, (01)00880304521162(17)180522(10)348190, (01)00880304521162(17)181101(10)265750, (01)00880304521162(17)181130(10)851110, (01)00880304521162(17)190626(10)549350, (01)00880304521162(17)190731(10)266450, (01)00880304521162(17)190828(10)301440, (01)00880304521162(17)191125(10)188860, (01)00880304521162(17)200128(10)464070, (01)00880304521162(17)200206(10)994620, (01)00880304521162(17)200506(10)701410, (01)00880304521162(17)200506(10)939800, (01)00880304521162(17)200608(10)112710, (01)00880304521162(17)200609(10)119970, (01)00880304521162(17)200710(10)375010, (01)00880304521162(17)200729(10)661210, (01)00880304521162(17)200811(10)661220, (01)00880304521162(17)200930(10)205950, (01)00880304521162(17)210119(10)596580, (01)00880304521162(17)210218(10)774500, (01)00880304521162(17)210310(10)997550, (01)00880304521162(17)210502(10)145740, (01)00880304521162(17)210721(10)291880, (01)00880304521162(17)210824(10)799200, (01)00880304521162(17)210923(10)397020, (01)00880304521162(17)211112(10)552570, (01)00880304521162(17)210824(10)799200R, (01)00880304521162(17)211112(10)552570R, (01)00880304521162(17)230115(10)070340, (01)00880304521162(17)230202(10)708360, (01)00880304521162(17)230202(10)708380, (01)00880304521162(17)230202(10)708350, (01)00880304521162(17)230205(10)810080, (01)00880304521162(17)230224(10)225020, (01)00880304521162(17)230228(10)618510, (01)00880304521162(17)230223(10)737390, (01)00880304521162(17)230407(10)618520, (01)00880304521162(17)230415(10)388640, (01)00880304521162(17)230411(10)487350, (01)00880304521162(17)230416(10)737370, (01)00880304521162(17)230416(10)737400, (01)00880304521162(17)230422(10)275390, (01)00880304521162(17)230430(10)950440, (01)00880304521162(17)230514(10)548650, (01)00880304521162(17)230510(10)708400, (01)00880304521162(17)230625(10)848360, (01)00880304521162(17)210119(10)596580R, (01)00880304521162(17)230411(10)487350R, (01)00880304521162(17)210721(10)291880R 291880R.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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