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

Is my product affected?

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

• UPC 00880304521162

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. has recalled approximately 230,001 units of its StageOne Select Hip Stem Cement Spacer Mold (17 X 200 MM, Silicone, Sterile) due to a potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. The affected product was distributed worldwide and to numerous U.S. states. The recall involves specific lot numbers and UDI numbers identified in the recall notice.

The source document does not specify a remedy or recommended action for consumers who may have obtained this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Distribution: 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, Nev Quantity: 230,001 Lot/code info: ***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)008803045

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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