Z-1641-2020 Class II Terminated
FDA device recall Z-1641-2020 was initiated by Biomet, Inc. on February 26, 2020 and is designated Class II. Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. The recall status is terminated (terminated July 29, 2021). Affected quantity: 230, 001.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- February 26, 2020
- Termination Date
- July 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 230, 001
Product Description
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Reason for Recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Distribution Pattern
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.
Code Information
***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(10)132370, (01)00880304521056(17)200813(10)820480, (01)00880304521056(17)200827(10)931920, (01)00880304521056(17)200903(10)952920, (01)00880304521056(17)201106(10)627850, (01)00880304521056(17)201110(10)816100, (01)00880304521056(17)201204(10)990340, (01)00880304521056(17)210112(10)152520, (01)00880304521056(17)210111(10)334530, (01)00880304521056(17)210209(10)362320, (01)00880304521056(17)210209(10)362330, (01)00880304521056(17)210303(10)966960, (01)00880304521056(17)210524(10)829830, (01)00880304521056(17)210921(10)322800, (01)00880304521056(17)210927(10)322790, (01)00880304521056(17)220107(10)322810, (01)00880304521056(17)220107(10)322810R, (01)00880304521056(17)220621(10)827140, (01)00880304521056(17)210209(10)362330R, (01)00880304521056(17)220726(10)229620, (01)00880304521056(17)230120(10)757600, (01)00880304521056(17)230124(10)808680, (01)00880304521056(17)230209(10)118530, (01)00880304521056(17)230209(10)118540, (01)00880304521056(17)230209(10)972010, (01)00880304521056(17)230216(10)757500, (01)00880304521056(17)230216(10)757510, (01)00880304521056(17)230217(10)808690, (01)00880304521056(17)230219(10)827120, (01)00880304521056(17)230217(10)827150, (01)00880304521056(17)230302(10)118520, (01)00880304521056(17)230302(10)118560, (01)00880304521056(17)230301(10)884560, (01)00880304521056(17)230308(10)827900, (01)00880304521056(17)230417(10)827870, (01)00880304521056(17)230425(10)431600, (01)00880304521056(17)230425(10)884550, (01)00880304521056(17)240513(10)455990, (01)00880304521056(17)240517(10)479080, (01)00880304521056(17)240608(10)569440, (01)00880304521056(17)240614(10)479070, (01)00880304521056(17)240615(10)479090, (01)00880304521056(17)240620(10)479100, (01)00880304521056(17)240610(10)569390, (01)00880304521056(17)240614(10)569400, (01)00880304521056(17)240612(10)569410, (01)00880304521056(17)240609(10)569420, (01)00880304521056(17)240614(10)569450, (01)00880304521056(17)240614(10)569490, (01)00880304521056(17)230219(10)827120R, (01)00880304521056(17)230425(10)884550R, (01)00880304521056(17)240830(10)455980, (01)00880304521056(17)240925(10)985690, (01)00880304521056(17)240926(10)986830, (01)00880304521056(17)240925(10)990920, (01)00880304521056(17)241003(10)990000, (01)00880304521056(17)241011(10)987900, (01)00880304521056(17)241024(10)990680, (01)00880304521056(17)250102(10)978380