FDA Device recall Z-1657-2020
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406
- 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 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406 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-1657-2020 |
| 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 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 860650, 215420, 555520, 583840, 089450, 283340, 132840, 413160, 058040, 181870, 408950, 4…***Lot Numbers*** 860650, 215420, 555520, 583840, 089450, 283340, 132840, 413160, 058040, 181870, 408950, 409050, 409080, 851260, 234340, 338950, 581670, 201250, 518970, 024030, 030980, 166060, 219540, 219550, 219570, 429550, 296820, 296830, 296840, 296850, 298770, 041360, 041370, 041380, 146580, 146590, 443590, 844530, 115350, 251890, 326910, 630420, 870230, 389150, 572890, 698780, 970100, 199840, 481720, 398100, 398130, 789650, 789640, 877250, 202480, 202490, 398090, 398080, 398100R, 789650R, 256430, 256450, 256440, 323790, 398090R, 398130R, 630420R, 789640R, 349500, 710600, 846440, 846420, 846490, 915380, 915370, 962800, 122840, 995670, 995680, 592030, 467400, 467410, 467420, 736490, 073190, 372270, 107950, 186460, 277550. ***UDI Numbers*** (01)00880304551107(17)141007(10)860650, (01)00880304551107(17)141112(10)215420, (01)00880304551107(17)181231(10)555520, (01)00880304551107(17)181231(10) |
|---|
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-1657-2020%22
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