FDA Device recall Z-1659-2020
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410
- 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 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410 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-1659-2020 |
| 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 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 860790, 215440, 381650, 555570, 089680, 283390, 509720, 657620, 132830, 372720, 097250, 2…***Lot Numbers*** 860790, 215440, 381650, 555570, 089680, 283390, 509720, 657620, 132830, 372720, 097250, 281740, 409230, 409310, 409330, 196720, 196730, 338940, 452050, 581680, 776930, 386800, 233600, 079220, 204510, 262240, 429580, 595980, 849850, 849760, 041390, 041400, 041410, 041420, 041430, 245100, 245110, 245120, 245130, 779360, 915810, 115430, 152270, 326930, 441890, 665300, 924180, 009460, 169730, 389160, 424210, 723180, 723190, 743960, 199850, 970110, 390630, 732410, 398180, 398230, 398190, 398210, 398220, 789770, 789720, 789810, 877270, 202530, 789770R, 789810R, 202530R, 398190R, 674330, 674370, 809050, 325580, 916160, 916170, 916180, 916200, 219810, 398230R, 789720R, 349550, 349560, 349540, 710640, 710650, 846810, 713920, 847000, 847030, 847050, 847140, 846860, 847160, 399490, 399500, 417030, 417010, 417020, 073050, 455050, 704980, 799220, 838250, 918280, 532640, 532 |
|---|
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-1659-2020%22
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