Class 2 Device Recall BIOMET Orthopedics

• Date Initiated by Firm: February 26, 2020
• Date Posted: April 03, 2020
• Recall Status: Terminated on July 29, 2021
• Recall Number: Z-1638-2020
• Recall Event ID: 85153
• 510(K)Number: K080979 K161166
• Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
• Product: BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
• Code Information: ***Lot Numbers*** 623210, 636020, 822620, 865060, 823110, 922950, 234200, 556590, 801160, 919620, 115650, 401230, 382910, 508910, 189900, 534730, 009800, 280090, 844520, 297620, 554620, 744820, 431230, 913690, 940260, 745380, 981490, 251350, 364310, 675220, 940100, 990100, 327990, 396630, 903720, 295160, 374220, 679700, 679710, 716140, 952890, 496420, 496430, 820430, 816090, 921260, 496440, 496460, 038620, 292650, 441830, 362260, 683620, 966920, 829800, 949730, 591230, 988900, 988910, 826960, 757380, 988910R, 229040, 757370, 757390, 757400, 826970, 893670, 826990, 757410, 826930, 893720, 893710, 808600, 778290, 915190, 808580, 884480, 884490, 920520, 920530, 920540, 920530R, 455880, 455900, 696930, 737370, 737380, 455910, 569270, 569280, 569290, 569300, 569320, 569330, 569340, 569360, 569370, 569380, 696800, 696820, 696830, 696840, 696850, 696860, 696890, 696900, 696910, 765040, 765050, 765060, 765070, 765080, 672450, 672460, 672640, 672650, 672770, 737700, 672480, 696920, 694950, 694960, 671920, 672000. ***UDI Numbers*** (01)00880304521100(17)180220(10)623210, (01)00880304521100(17)180221(10)636020, (01)00880304521100(17)180307(10)822620, (01)00880304521100(17)180308(10)865060, (01)00880304521100(17)180313(10)823110, (01)00880304521100(17)180320(10)922950, (01)00880304521100(17)180503(10)234200, (01)00880304521100(17)180628(10)556590, (01)00880304521100(17)180724(10)801160, (01)00880304521100(17)180808(10)919620, (01)00880304521100(17)180819(10)115650, (01)00880304521100(17)180909(10)401230, (01)00880304521100(17)190101(10)382910, (01)00880304521100(17)190113(10)508910, (01)00880304521100(17)190306(10)189900, (01)00880304521100(17)190426(10)534730, (01)00880304521100(17)190814(10)009800, (01)00880304521100(17)190827(10)280090, (01)00880304521100(17)190827(10)844520, (01)00880304521100(17)190923(10)297620, (01)00880304521100(17)190930(10)554620, (01)00880304521100(17)191024(10)744820, (01)00880304521100(17)191103(10)431230, 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(01)00880304521100(17)201215(10)038620, (01)00880304521100(17)210112(10)292650, (01)00880304521100(17)210120(10)441830, (01)00880304521100(17)210201(10)362260, (01)00880304521100(17)210209(10)683620, (01)00880304521100(17)210317(10)966920, (01)00880304521100(17)210524(10)829800, (01)00880304521100(17)210604(10)949730, (01)00880304521100(17)210728(10)591230, (01)00880304521100(17)220429(10)988900, (01)00880304521100(17)220429(10)988910, (01)00880304521100(17)220620(10)826960, (01)00880304521100(17)220622(10)757380, (01)00880304521100(17)220429(10)988910R, (01)00880304521100(17)220727(10)229040, (01)00880304521100(17)221022(10)757370, (01)00880304521100(17)221021(10)757390, (01)00880304521100(17)221021(10)757400, (01)00880304521100(17)221024(10)826970, (01)00880304521100(17)221021(10)893670, (01)00880304521100(17)221026(10)826990, (01)00880304521100(17)221025(10)757410, (01)00880304521100(17)221103(10)826930, (01)00880304521100(17)221026(10)893720, (01)00880304521100(17)221228(10)893710, 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• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-372-1687
• Manufacturer Reason for Recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWY and Original Applicant = BIOMET MANUFACTURING CORP.; 510(K)s with Product Code = KWY and Original Applicant = BIOMET, INC.