FDA Device recall Z-1649-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196
- 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 200 MM, Silicone, Sterile, Item 431196 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-1649-2020 |
| 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 200 MM, Silicone, Sterile, Item 431196.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 188860, 326860, 558630, 628180, 977670, 116350, 122520, 437230, 437290, 740330, 341070, 5…***Lot Numbers*** 188860, 326860, 558630, 628180, 977670, 116350, 122520, 437230, 437290, 740330, 341070, 576690, 789080, 063540, 555070, 916280, 167510, 200790, 388910, 551820, 408270, 135820, 359260, 726800, 589000, 739960, 056940, 188810, 846790, 043650, 061850, 356930, 817130, 817180, 374980, 655520, 655530, 655540, 940150, 205910, 745770, 771020, 771030, 030880, 774440, 803790, 997470, 997500, 336220, 291950, 130830, 396920, 396930, 564620, 777740, 323510, 633930, 633940, 655650, 817180R, 548570, 946280, 116220, 438820, 453240, 224260, 438760, 453250, 916090, 916100, 946330, 295870, 431490, 070870, 070880, 438790, 388350, 548590, 737050, 275360, 359630, 712130, 034750, 275350, 737040, 950390, 974350, 989000, 042720, 144790, 179610, 478530, 478580, 478590, 639710, 639720, 639730, 639740, 639770, 639700, 262090, 262110, 404030, 404070, 717660, 717670, 717700, 717710, 717720, |
|---|
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-1649-2020%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.