BIOMET StageOne Select — Class II medical device recall Z-1651-2020
Terminated recall by Biomet, Inc., reported 2020-04-15, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
| Recall number | Z-1651-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-02-26 |
| Classified | 2020-04-03 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-07-29 |
| Distributed | 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 |
| Countries outside the US | MX |
| Quantity | 230,001 |
| UPC / GTIN / UDI-DI | 00880304521131 |
| Lot numbers | 029320, 035010, 042970, 063880, 066020, 070370, 073260, 073270, 077620, 077630, 091520, 092850, 104910, 110750, 143910, 157950, 160630, 164220, 164270, 164320, 164320R, 179530, 188840, 188850, 224890, 224900, 224930, 224930R, 224940, 224950, 275380, 291870, 291870R, 291970, 295910, 301450, 326900, 326920, 356080, 359270 and 77 more |
| Model numbers | 431198 |
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Reason for recall
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1651-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.