FDA Device recall Z-1652-2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199 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-1652-2020 |
| 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 Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Reason
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Identifiers
| code_info | ***Lot Numbers*** 288190, 288210, 580430, 612120, 574610, 521820, 736490, 406850, 767250, 348190, 265750, 8…***Lot Numbers*** 288190, 288210, 580430, 612120, 574610, 521820, 736490, 406850, 767250, 348190, 265750, 851110, 549350, 266450, 301440, 188860, 464070, 994620, 701410, 939800, 112710, 119970, 375010, 661210, 661220, 205950, 596580, 774500, 997550, 145740, 291880, 799200, 397020, 552570, 799200R, 552570R, 070340, 708360, 708380, 708350, 810080, 225020, 618510, 737390, 618520, 388640, 487350, 737370, 737400, 275390, 950440, 548650, 708400, 848360, 596580R, 487350R,***UDI Numbers*** (01)00880304521162(17)160828(10)288190, (01)00880304521162(17)160828(10)288210, (01)00880304521162(17)170128(10)580430, (01)00880304521162(17)170528(10)612120, (01)00880304521162(17)170828(10)574610, (01)00880304521162(17)171101(10)521820, (01)00880304521162(17)180115(10)736490, (01)00880304521162(17)180121(10)406850, (01)00880304521162(17)180301(10)767250, (01)00880304521162(17)180522(10)348190, (01)00880304521162(17)181101(10)265750, (01)0 |
|---|
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-1652-2020%22
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