FDA Device recall Z-1661-2020
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414
- 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 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414 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-1661-2020 |
| 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 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 860990, 215460, 555600, 583870, 089720, 283410, 657770, 148690, 412910, 181860, 357240, 4…***Lot Numbers*** 860990, 215460, 555600, 583870, 089720, 283410, 657770, 148690, 412910, 181860, 357240, 409510, 409570, 196740, 234330, 338970, 816850, 723210, 262260, 039780, 399440, 399450, 776900, 303400, 587270, 988280, 152280, 481410, 817140, 817150, 096260, 313250, 723230, 723240, 429710, 429720, 637380, 398290, 398310, 789830, 877380, 817140R, 972000, 971990, 637380R, 776900R, 809120, 583870R, 398290R, 096260R, 398310R, 915410, 914640, 914650, 963790, 962850, 995720, 995760, 153910, 153920, 277690, 277720, 277750, 484740, 723360, 197930, 736570. ***UDI Numbers*** (01)00880304551114(17)141007(10)860990, (01)00880304551114(17)141112(10)215460, (01)00880304551114(17)181202(10)555600, (01)00880304551114(17)181231(10)583870, (01)00880304551114(17)190206(10)089720, (01)00880304551114(17)190319(10)283410, (01)00880304551114(17)190327(10)657770, (01)00880304551114(17)190609(10)148690, (01)00880304551114(17)19 |
|---|
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-1661-2020%22
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