Biomet, Inc.: BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

Recall number

Z-1646-2020

Recalling firm

Biomet, Inc.

Product

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

Status

Terminated

Initiated

2020-02-26

Posted

2020-04-03

Terminated

2021-07-29

Reason

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

Root cause

Process control

Action

On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.

Quantity

230,001

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, 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.

Lot, serial or model codes

***Lot Numbers*** 087760, 558520, 558530, 654110, 469440, 926010, 718110, 083550, 341040, 474120, 662900, 306900, 914850, 265670, 551790, 941370, 941390, 817670, 158400, 141900, 188770, 061830, 463840, 364220, 816770, 816790, 374950, 655500, 792150, 092520, 655490, 770990, 683080, 683090, 981350, 997440, 997450, 912470, 912480, 624170, 624180, 665060, 552360, 265670R, 306900R, 232960, 233000, 233060, 547570, 547670, 552360R, 226520, 809460, 547650, 547680, 809270, 071410, 071430, 071450, 164150, 223370, 431360, 487280, 552580, 401640, 401650, 401670, 295510, 941390R, 226530, 143780, 303410, 737410, 988920, 223390, 295520, 920600, 683080R, 639430, 639490, 639540, 639550, 639510, 639530, 639560, 639590, 777450, 777570, 777600, 052660, 312640, 455040, 639440, 639480, 765330, 765340, 777390, 778120, 778130, 813840, 877540, 037550, 210740, 547570R, 709650, 777290, 777300, 788910, 807230, 807240, 856340, 029030, 029050, 807260, 330970, 813820, 465410, 488050, 554620, 554630, 554660, 605690, 657890, 758500, 807230R, 810950, 865860, 865890, 910090, 910120, 946910. ***UDI 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41003(10)807230R, (01)00880304521179(17)241217(10)810950, (01)00880304521179(17)241217(10)865860, (01)00880304521179(17)241218(10)865890, (01)00880304521179(17)250111(10)910090, (01)00880304521179(17)250111(10)910120, (01)00880304521179(17)250111(10)946910

510(k) numbers

["K080979","K161166"]

PMA numbers

not on file

Product code

KWY

Firm FEI

1825034

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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