Biomet, Inc.: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

Is my product affected?

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

• UPC 00880304521131

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

What happened

Biomet, Inc. has recalled approximately 230,001 units of BIOMET StageOne Select Hip Stem Cement Spacer Mold (15 X 200 MM, Silicone, Sterile, Item 431198) distributed worldwide and to multiple U.S. states. The recall was initiated due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters for the affected devices. The recalled units span numerous lot numbers and UDI codes, with expiration dates ranging from July 2016 through early 2018.

The recall record does not specify a remedy or corrective action for consumers who may have received affected units.

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*** 104910, 157950, 326900, 326920, 652840, 684040, 471600, 593520, 940120, 437300, 091520, 474150, 576700, 110750, 672080, 143910, 713260, 359270, 529160, 160630, 301450, 188850, 188840, 886920, 066020, 364260, 077620, 077630, 429820, 492480, 661200, 092850, 771050, 997420, 997410, 291970, 291870, 799190, 397000, 564140, 564130, 997410R, 809850, 809870, 809910, 224890, 548620, 809890, 916180, 070370, 224900, 224940, 224950, 164220, 164270, 164320, 224930, 295910, 388560, 388610, 388630, 552720, 552740, 388620, 552730, 737160, 875440, 989030, 291870R, 359270R, 799190R, 275380, 035010, 950420, 042970, 179530, 388620R, 717600, 717630, 777730, 356080, 717610, 717640, 777680, 777720, 864800, 864810, 864820, 864830, 879760, 063880, 164320R, 809910R, 224930R, 777710, 580090, 789080, 807580, 029320, 807550, 807560, 807590, 717620, 073260, 073270, 364280, 364300, 488070, 525680, 554710, 641750, 641840, 673840, 770190, 835130, 885470, 947000. ***UDI Numbers*** (01)00880304521131(17)160728(10)104910, (01)00880304521131(17)160728(10)157950, (01)00880304521131(17)160828(10)326900, (01)00880304521131(17)160728(10)326920, (01)00880304521131(17)160928(10)652840, (01)00880304521131(17)160930(10)684040, (01)00880304521131(17)170428(10)471600, (01)00880304521131(17)170528(10)593520, (01)00880304521131(17)170928(10)940120, (01)00880304521131(17)171128(10)437300, (01)00880304521131(17)171201(10)091520, (01)00880304521131(17)180204(10)474150, (01)00880304521131(17)180212(10)576700,

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.2020-02-26
• BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.2020-02-26

All FDA (Device enforcement) recalls