FDA Device recall Z-1651-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198
- 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 200 MM, Silicone, Sterile, Item 431198 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-1651-2020 |
| 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 200 MM, Silicone, Sterile, Item 431198.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 104910, 157950, 326900, 326920, 652840, 684040, 471600, 593520, 940120, 437300, 091520, 4…***Lot Numbers*** 104910, 157950, 326900, 326920, 652840, 684040, 471600, 593520, 940120, 437300, 091520, 474150, 576700, 110750, 672080, 143910, 713260, 359270, 529160, 160630, 301450, 188850, 188840, 886920, 066020, 364260, 077620, 077630, 429820, 492480, 661200, 092850, 771050, 997420, 997410, 291970, 291870, 799190, 397000, 564140, 564130, 997410R, 809850, 809870, 809910, 224890, 548620, 809890, 916180, 070370, 224900, 224940, 224950, 164220, 164270, 164320, 224930, 295910, 388560, 388610, 388630, 552720, 552740, 388620, 552730, 737160, 875440, 989030, 291870R, 359270R, 799190R, 275380, 035010, 950420, 042970, 179530, 388620R, 717600, 717630, 777730, 356080, 717610, 717640, 777680, 777720, 864800, 864810, 864820, 864830, 879760, 063880, 164320R, 809910R, 224930R, 777710, 580090, 789080, 807580, 029320, 807550, 807560, 807590, 717620, 073260, 073270, 364280, 364300, 488070, 5 |
|---|
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-1651-2020%22
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