OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left — Class II medical device recall Z-0082-2019
Terminated recall by Orthosensor, Inc., reported 2018-10-17, distributed in CA, FL, IL, IN, MI, NC, NY. Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
| Recall number | Z-0082-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosensor, Inc., Dania, FL, United States |
| Recall initiated | 2018-07-12 |
| Classified | 2018-10-05 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-06-27 |
| Distributed | CA, FL, IL, IN, MI, NC, NY |
| Countries outside the US | AU |
| Quantity | 41 devices |
| UPC / GTIN / UDI-DI | 00816818021430 |
| Lot numbers | 20568, 20575, 20581, 20584, 20621, 20623, 20628 |
| Model numbers | ZBH-PSNCREF311-L |
Product
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Reason for recall
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
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-0082-2019. 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.