FDA Device recall Z-1646-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193
- 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, 15 X 155 MM, Silicone, Sterile, Item 431193 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-1646-2020 |
| 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, 15 X 155 MM, Silicone, Sterile, Item 431193.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 087760, 558520, 558530, 654110, 469440, 926010, 718110, 083550, 341040, 474120, 662900, 3…***Lot Numbers*** 087760, 558520, 558530, 654110, 469440, 926010, 718110, 083550, 341040, 474120, 662900, 306900, 914850, 265670, 551790, 941370, 941390, 817670, 158400, 141900, 188770, 061830, 463840, 364220, 816770, 816790, 374950, 655500, 792150, 092520, 655490, 770990, 683080, 683090, 981350, 997440, 997450, 912470, 912480, 624170, 624180, 665060, 552360, 265670R, 306900R, 232960, 233000, 233060, 547570, 547670, 552360R, 226520, 809460, 547650, 547680, 809270, 071410, 071430, 071450, 164150, 223370, 431360, 487280, 552580, 401640, 401650, 401670, 295510, 941390R, 226530, 143780, 303410, 737410, 988920, 223390, 295520, 920600, 683080R, 639430, 639490, 639540, 639550, 639510, 639530, 639560, 639590, 777450, 777570, 777600, 052660, 312640, 455040, 639440, 639480, 765330, 765340, 777390, 778120, 778130, 813840, 877540, 037550, 210740, 547570R, 709650, 777290, 777300, 788910, 807 |
|---|
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-1646-2020%22
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