ECHO POR FMRL NC 9X125 — Class II medical device recall Z-0300-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-01-10, distributed nationwide. Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and act
| Recall number | Z-0300-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-06-05 |
| Classified | 2017-12-29 |
| Reported by FDA | 2018-01-10 |
| Terminated | 2018-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CA, NL |
| Reason classes | labeling |
| Lot numbers | 410150 |
| Model numbers | 192009 |
Product
ECHO POR FMRL NC 9X125, model # 192009
Reason for recall
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
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-0300-2018. 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.