Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1652-2020)

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.

Class II

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

***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.

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.

Voluntary: Firm initiated