BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
This recall has been terminated (originally issued April 3, 2020).
- Company
- Biomet, Inc.
- Recall Initiated
- February 26, 2020
- Posted
- April 3, 2020
- Terminated
- July 29, 2021
- Recall Number
- Z-1659-2020
- Quantity
- 230,001
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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, 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 / Code Info
***Lot Numbers*** 860790, 215440, 381650, 555570, 089680, 283390, 509720, 657620, 132830, 372720, 097250, 281740, 409230, 409310, 409330, 196720, 196730, 338940, 452050, 581680, 776930, 386800, 233600, 079220, 204510, 262240, 429580, 595980, 849850, 849760, 041390, 041400, 041410, 041420, 041430, 245100, 245110, 245120, 245130, 779360, 915810, 115430, 152270, 326930, 441890, 665300, 924180, 009460, 169730, 389160, 424210, 723180, 723190, 743960, 199850, 970110, 390630, 732410, 398180, 398230, 398190, 398210, 398220, 789770, 789720, 789810, 877270, 202530, 789770R, 789810R, 202530R, 398190R, 674330, 674370, 809050, 325580, 916160, 916170, 916180, 916200, 219810, 398230R, 789720R, 349550, 349560, 349540, 710640, 710650, 846810, 713920, 847000, 847030, 847050, 847140, 846860, 847160, 399490, 399500, 417030, 417010, 417020, 073050, 455050, 704980, 799220, 838250, 918280, 532640, 532660, 028890, 585150, 525420,***UDI Numbers*** (01)00880304551091(17)141007(10)860790, (01)00880304551091(17)141112(10)215440, (01)00880304551091(17)181130(10)381650, (01)00880304551091(17)181231(10)555570, (01)00880304551091(17)190213(10)089680, (01)00880304551091(17)190225(10)283390, (01)00880304551091(17)190320(10)509720, (01)00880304551091(17)190331(10)657620, (01)00880304551091(17)190505(10)132830, (01)00880304551091(17)190528(10)372720, (01)00880304551091(17)190731(10)097250, (01)00880304551091(17)190818(10)281740, (01)00880304551091(17)190826(10)409230, (01)00880304551091(17)190826(10)409310, (01)00880304551091(17)190826(10)409330, (01)00880304551091(17)191103(10)196720, (01)00880304551091(17)191103(10)196730, (01)00880304551091(17)191111(10)338940, (01)00880304551091(17)191119(10)452050, (01)00880304551091(17)191209(10)581680, (01)00880304551091(17)191223(10)776930, (01)00880304551091(17)200314(10)386800, (01)00880304551091(17)200330(10)233600, (01)00880304551091(17)200512(10)079220, (01)00880304551091(17)200521(10)204510, (01)00880304551091(17)200522(10)262240, (01)00880304551091(17)200610(10)429580, (01)00880304551091(17)200706(10)595980, (01)00880304551091(17)200725(10)849850, (01)00880304551091(17)200727(10)849760, (01)00880304551091(17)201111(10)041390, (01)00880304551091(17)201111(10)041400, (01)00880304551091(17)201111(10)041410, (01)00880304551091(17)201110(10)041420, (01)00880304551091(17)201111(10)041430, (01)00880304551091(17)201130(10)245100, (01)00880304551091(17)201130(10)245110, (01)00880304551091(17)201130(10)245120, (01)00880304551091(17)201130(10)245130, (01)00880304551091(17)210119(10)779360, (01)00880304551091(17)210201(10)915810, (01)00880304551091(17)210217(10)115430, (01)00880304551091(17)210224(10)152270, (01)00880304551091(17)210307(10)326930, (01)00880304551091(17)210321(10)441890, (01)00880304551091(17)210407(10)665300, (01)00880304551091(17)210425(10)924180, (01)00880304551091(17)210503(10)009460, (01)00880304551091(17)210517(10)169730, (01)00880304551091(17)210603(10)389160, (01)00880304551091(17)210606(10)424210, (01)00880304551091(17)210705(10)723180, (01)00880304551091(17)210705(10)723190, (01)00880304551091(17)210711(10)743960, (01)00880304551091(17)210808(10)199850, (01)00880304551091(17)210803(10)970110, (01)00880304551091(17)210831(10)390630, (01)00880304551091(17)210929(10)732410, (01)00880304551091(17)220518(10)398180, (01)00880304551091(17)220523(10)398230, (01)00880304551091(17)220523(10)398190, (01)00880304551091(17)220603(10)398210, (01)00880304551091(17)220603(10)398220, (01)00880304551091(17)220601(10)789770, (01)00880304551091(17)220612(10)789720, (01)00880304551091(17)220611(10)789810, (01)00880304551091(17)220608(10)877270, (01)00880304551091(17)220701(10)202530, (01)00880304551091(17)220601(10)789770R, (01)00880304551091(17)220611(10)789810R, (01)00880304551091(17)220701(10)202530R, (01)00880304551091(17)220523(10)398190R, (01)00880304551091(17)221018(10)674330, (01)00880304551091(17)221018(10)674370, (01)00880304551091(17)221106(10)809050, (01)00880304551091(17)221211(10)325580, (01)00880304551091(17)230205(10)916160, (01)00880304551091(17)230204(10)916170, (01)00880304551091(17)230205(10)916180, (01)00880304551091(17)230206(10)916200, (01)00880304551091(17)230330(10)219810, (01)00880304551091(17)220523(10)398230R, (01)00880304551091(17)220612(10)789720R, (01)00880304551091(17)240203(10)349550, (01)00880304551091(17)240205(10)349560, (01)00880304551091(17)240210(10)349540, (01)00880304551091(17)240306(10)710640, (01)00880304551091(17)240228(10)710650, (01)00880304551091(17)240307(10)846810, (01)00880304551091(17)240308(10)713920, (01)00880304551091(17)240307(10)847000, (01)00880304551091(17)240307(10)847030, (01)00880304551091(17)240313(10)847050, (01)00880304551091(17)240309(10)847140, (01)00880304551091(17)240314(10)846860, (01)00880304551091(17)240326(10)847160, (01)00880304551091(17)240416(10)399490, (01)00880304551091(17)240416(10)399500, (01)00880304551091(17)240501(10)417030, (01)00880304551091(17)240502(10)417010, (01)00880304551091(17)240502(10)417020, (01)00880304551091(17)240621(10)073050, (01)00880304551091(17)240628(10)455050, (01)00880304551091(17)240802(10)704980, (01)00880304551091(17)240802(10)799220, (01)00880304551091(17)240801(10)838250, (01)00880304551091(17)240731(10)918280, (01)00880304551091(17)240912(10)532640, (01)00880304551091(17)240912(10)532660, (01)00880304551091(17)241008(10)028890, (01)00880304551091(17)241110(10)585150, (01)00880304551091(17)241109(10)525420, (01)00880304551091(17)220603(10)398210R 398210R.
Root Cause
Process control
Action Taken
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.