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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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