FDA Device recall Z-1655-2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213
- 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, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213 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-1655-2020 |
| 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, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 027900, 670510, 371230, 836660, 602430, 008340, 008360, 008380, 162240, 162250, 700500, 1…***Lot Numbers*** 027900, 670510, 371230, 836660, 602430, 008340, 008360, 008380, 162240, 162250, 700500, 186490, 377390, 658100, 658110, 658120, 658130, 473170, 912530, 086110, 571910, 230030, 230050, 658620, 658640, 170090, 170070, 527210, 527930, 600440, 600500, 239200, 239400, 680240, 729290, 844520, 978070, 260560, 413060, 747280, 845740, 996980, 215490, 381730, 447360, 627970, 868840, 070900, 339490, 600720, 771050, 182020, 325410, 610630, 745470, 251400, 557660, 847720, 858270, 157440, 328640, 628360, 628430, 790270, 238740, 514580, 679770, 953140, 197720, 336630, 152540, 527470, 647360, 945690, 057590, 229330, 759540, 949860, 258720, 332610, 787070, 595080, 595090, 737830, 737840, 737850, 755150, 755160, 755170, 737860, 755120, 755130, 755140, 757300, 202130, 202460, 733920R, 733910R, 732040, 118130, 416640R, 141060, 141040, 378370, 378390, 765990, 766020, 766030, 766050 |
|---|
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-1655-2020%22
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