FDA Device recall Z-1644-2020

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191

FDA Device
Class II
terminated
Published 2020-04-15

On 2020-04-15 the FDA classified a Class II recall of BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191 by Biomet, citing potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1644-2020
Classification	Class II
Status	terminated
Initiated	2020-02-26
Published	2020-04-15
Last updated	2026-09-13 11:55 UTC
Company	Biomet
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY

Product

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

Reason

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

Identifiers

code_info	*Lot Numbers* 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 9… *Lot Numbers* 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500

code_info

***Lot Numbers*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 9…

***Lot Numbers*** 996010, 795510, 603900, 891790, 437190, 735730, 403040, 474110, 766880, 819080, 949560, 982930, 063520, 277390, 348170, 649140, 649130, 915350, 093590, 167540, 265560, 551780, 135780, 135790, 584730, 090420, 359020, 359030, 262330, 179770, 467060, 726970, 158190, 157740, 740300, 056340, 056350, 188720, 188730, 188740, 388660, 388650, 388690, 354050, 354040, 061810, 354020, 816350, 816380, 077600, 077610, 124510, 429530, 429570, 429590, 655290, 655270, 663150, 803110, 940130, 092340, 110940, 205710, 757130, 958250, 332910, 505420, 505440, 774400, 774410, 774420, 967000, 967010, 967020, 121310, 842580, 842590, 842680, 842790, 054790, 291800, 799090, 799100, 799120, 396760, 396790, 396750, 396770, 777410, 777440, 092340R, 655270R, 865810, 865820, 865830, 945970, 774410R, 437480, 437510, 453400, 477530, 116030, 437430, 437540, 437550, 437560, 453420, 453490, 453500

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1644-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.