FDA Device recall Z-1641-2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184
- 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 with Insert, 60 MM, Silicone, Sterile, Item 431184 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-1641-2020 |
| 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 with Insert, 60 MM, Silicone, Sterile, Item 431184.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 104420, 982400, 982410, 321650, 321010, 623250, 922960, 031220, 997610, 556620, 122900, 3…***Lot Numbers*** 104420, 982400, 982410, 321650, 321010, 623250, 922960, 031220, 997610, 556620, 122900, 382940, 419310, 474090, 758580, 009860, 913730, 188870, 640320, 790260, 132370, 820480, 931920, 952920, 627850, 816100, 990340, 152520, 334530, 362320, 362330, 966960, 829830, 322800, 322790, 322810, 322810R, 827140, 362330R, 229620, 757600, 808680, 118530, 118540, 972010, 757500, 757510, 808690, 827120, 827150, 118520, 118560, 884560, 827900, 827870, 431600, 884550, 455990, 479080, 569440, 479070, 479090, 479100, 569390, 569400, 569410, 569420, 569450, 569490, 827120R, 884550R, 455980, 985690, 986830, 990920, 990000, 987900, 990680, 978380. ***UDI Numbers*** (01)00880304521056(17)160928(10)104420, (01)00880304521056(17)171228(10)982400, (01)00880304521056(17)171221(10)982410, (01)00880304521056(17)180122(10)321650, (01)00880304521056(17)180208(10)321010, (01)00880304521056(17)180308(10)623250, ( |
|---|
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-1641-2020%22
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