FDA Device recall Z-1658-2020
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408 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-1658-2020 |
| 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, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 860710, 215430, 555230, 583850, 089660, 283370, 132850, 372710, 372760, 181880, 357230, 4…***Lot Numbers*** 860710, 215430, 555230, 583850, 089660, 283370, 132850, 372710, 372760, 181880, 357230, 409110, 409190, 765360, 196690, 196700, 196710, 338960, 511930, 549800, 706840, 386790, 445290, 723200, 024040, 079210, 262220, 262230, 429560, 821040, 821050, 960990, 039770, 399430, 429450, 583060, 776890, 938560, 245080, 245090, 303380, 443600, 892230, 751870, 115420, 186520, 326920, 513020, 665290, 978020, 225130, 424200, 572910, 698790, 932210, 637420, 637430, 637440, 398110, 398120, 398140, 398150, 398160, 789690, 789700, 789670, 877260, 202510, 583060R, 572910R, 877260R, 398160R, 202500, 809040, 747440, 916120, 916130, 916140, 916150, 549800R, 349510, 349530, 349520, 710630, 710610, 846580, 846670, 846740, 895240, 915400, 963760, 996210, 996220, 713910, 980630, 094950, 094960, 094980, 455060, 705090, 798220, 325450, 250110, 255770, 250120, 350890, 541430. ***UDI Number |
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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-1658-2020%22
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