FDA Device recall Z-1654-2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209
- 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, 51 MM, Silicone, Sterile, Item 431209 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-1654-2020 |
| 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, 51 MM, Silicone, Sterile, Item 431209.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 411170, 928060, 453050, 008400, 008780, 162230, 160450, 160460, 160470, 078140, 212600, 4…***Lot Numbers*** 411170, 928060, 453050, 008400, 008780, 162230, 160450, 160460, 160470, 078140, 212600, 473150, 147200, 668750, 668810, 235310, 235260, 565730, 565740, 565780, 565800, 565750, 230020, 096010, 096030, 095830, 688290, 688390, 688400, 976900, 977070, 977080, 239190, 239390, 310050, 310180, 310200, 757930, 978060, 107630, 219920, 260550, 436940, 572340, 572350, 718010, 910910, 996970, 139640, 215600, 447340, 518820, 712320, 270170, 411560, 525340, 619980, 789360, 983800, 207230, 356350, 600710, 658360, 804860, 115880, 274120, 411240, 512260, 610620, 719040, 039580, 735560, 735570, 160950, 628310, 627970, 628320, 628330, 711810, 711820, 765470, 284700, 284710, 488480, 488490, 488500, 051450, 051460, 051470, 051480, 051490, 051500, 162780, 607690, 607700, 722770, 723210, 038660, 038670, 428720, 647320, 647330, 774580, 428700, 994880, 229280, 229290, 740300, 740310, |
|---|
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-1654-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.