BIOMET StageOne Hip Cement Spacer Mold with Insert — Class II medical device recall Z-1642-2020
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-1642-2020 |
|---|---|
| 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 |
| UPC / GTIN / UDI-DI | 00880304521063 |
| Lot numbers | 004800, 082110, 092470, 104440, 118580, 118580R, 118590, 184510, 231990, 232110, 295210, 357210, 362340, 362340R, 364330, 396650, 396650R, 455920, 464210, 474100, 508930, 569510, 602290, 630170, 734050, 740650, 757640, 757700, 757740, 757770, 800090, 816110, 827160, 827170, 854280, 868260, 884570, 911390, 911440, 911470 and 13 more |
| Model numbers | 431185 |
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
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-1642-2020. 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.