FDA Device recall Z-1645-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192
- 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, 13 X 145 MM, Silicone, Sterile, Item 431192 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-1645-2020 |
| 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, 13 X 145 MM, Silicone, Sterile, Item 431192.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 838930, 799860, 764700, 371690, 371700, 574530, 062130, 939190, 258290, 874960, 717990, 1…***Lot Numbers*** 838930, 799860, 764700, 371690, 371700, 574530, 062130, 939190, 258290, 874960, 717990, 135090, 341030, 262420, 789510, 843130, 843140, 020980, 063530, 258130, 306890, 554960, 916060, 143900, 369930, 713250, 068170, 135800, 387420, 266430, 817720, 424890, 271580, 467100, 158310, 158320, 158330, 063490, 188750, 188760, 388720, 847530, 061820, 354330, 354340, 816470, 816710, 374910, 374920, 374940, 670140, 655470, 792140, 655460, 722930, 792130, 092510, 205800, 364730, 655480, 759150, 771240, 799960, 770950, 770970, 064050, 981350, 691930, 683120, 683170, 683150, 803380, 691880, 912490, 912500, 624150, 624160, 444030, 564610, 563840, 996120, 777720, 777730, 866050, 866070, 444030R, 655460R, 205800R, 116150, 232830, 946080, 232790, 232820, 438450, 453800, 453820, 453840, 477550, 477580, 477590, 547510, 438360, 438420, 453810, 453850, 477570, 477600, 547520, 784740 |
|---|
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-1645-2020%22
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