Biomet Modular Primary Tibial Tray Implants — Class II medical device recall Z-2177-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-06-20, distributed in FL, GA, IN, MA, NM, UT, WI. One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay i
| Recall number | Z-2177-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-05-18 |
| Classified | 2018-06-12 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-03-31 |
| Distributed | FL, GA, IN, MA, NM, UT, WI |
| Countries outside the US | CA, MX |
| Quantity | 16 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00880304005310 |
| Lot numbers | 385340 |
| Model numbers | 141215 |
Product
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
Reason for recall
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
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-2177-2018. 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.