FDA Device recall Z-1653-2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207 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-1653-2020 |
| 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, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 964120, 668270, 595770, 400860, 854840, 867720, 867770, 386480, 539790, 700450, 930290, 2…***Lot Numbers*** 964120, 668270, 595770, 400860, 854840, 867720, 867770, 386480, 539790, 700450, 930290, 215340, 457040, 615020, 588170, 588180, 963900, 963890, 737920, 805810, 036350, 527200, 527910, 976890, 977050, 977060, 239180, 239350, 680230, 914070, 436930, 586660, 718000, 996950, 152820, 447320, 583910, 489590, 688970, 983790, 237740, 600740, 804850, 281760, 610610, 251390, 640340, 858260, 328590, 712140, 712150, 238320, 430100, 753810, 953120, 816080, 816070, 227680, 647310, 057570, 057580, 759520, 759530, 656320, 787060, 107920, 107930, 737780, 115700, 737760, 737770, 754930, 754940, 754960, 754970, 754980, 202410, 202420, 520120, 520130, 520140, 520150, 754960R, 705550, 964100R, 680230R, 807460, 825790R, 027710R, 766730, 520990, 520980, 521010, 234640, 234680, 208540R, 867750R, 347510, 347520, 348000, 347990, 318490, 318510, 318530, 318540, 337310, 337330, 350230, 33 |
|---|
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-1653-2020%22
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