Biomet, Inc.: BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

Is my product affected?

BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

• UPC 00880304521056

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

What happened

Biomet, Inc. is recalling approximately 230,001 units of BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile (Item 431184) due to a potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The affected products were distributed worldwide and throughout most U.S. states. The recall involves numerous lot numbers and includes specific UDI (Unique Device Identifier) codes that can be used to identify affected units.

The recall record does not specify a remedy or recommended action for affected consumers to take.

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*** 104420, 982400, 982410, 321650, 321010, 623250, 922960, 031220, 997610, 556620, 122900, 382940, 419310, 474090, 758580, 009860, 913730, 188870, 640320, 790260, 132370, 820480, 931920, 952920, 627850, 816100, 990340, 152520, 334530, 362320, 362330, 966960, 829830, 322800, 322790, 322810, 322810R, 827140, 362330R, 229620, 757600, 808680, 118530, 118540, 972010, 757500, 757510, 808690, 827120, 827150, 118520, 118560, 884560, 827900, 827870, 431600, 884550, 455990, 479080, 569440, 479070, 479090, 479100, 569390, 569400, 569410, 569420, 569450, 569490, 827120R, 884550R, 455980, 985690, 986830, 990920, 990000, 987900, 990680, 978380. ***UDI Numbers*** (01)00880304521056(17)160928(10)104420, (01)00880304521056(17)171228(10)982400, (01)00880304521056(17)171221(10)982410, (01)00880304521056(17)180122(10)321650, (01)00880304521056(17)180208(10)321010, (01)00880304521056(17)180308(10)623250, (01)00880304521056(17)180313(10)922960, (01)00880304521056(17)180329(10)031220, (01)00880304521056(17)180329(10)997610, (01)00880304521056(17)180617(10)556620, (01)00880304521056(17)180819(10)122900, (01)00880304521056(17)190106(10)382940, (01)00880304521056(17)190113(10)419310, (01)00880304521056(17)190425(10)474090, (01)00880304521056(17)190425(10)758580, (01)00880304521056(17)190819(10)009860, (01)00880304521056(17)191024(10)913730, (01)00880304521056(17)191125(10)188870, (01)00880304521056(17)200124(10)640320, (01)00880304521056(17)200512(10)790260, (01)00880304521056(17)200610

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, 64 MM, Silicone, Sterile, Item 431185.2020-02-26
• BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.2020-02-26

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