# FDA recall Z-1159-2021

> **ReNovo, Inc.** · Class II · device recall initiated 2021-01-19.

## Product

Various reprocessed products:   PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO;   PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg;  PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I);  PROVISION Reprocessed Conmed/ Linvatec Suture Retrievers/ Passers C6387  See updated product list attached for details.

## Reason for recall

Non-sterile product was shipped to customers labelled as sterile.

## Distribution

US Nationwide distribution in the states of CA, NJ and OR.

## Key facts

- **Recall number:** Z-1159-2021
- **Recalling firm:** ReNovo, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-19
- **Report date:** 2021-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bend, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2021

## Citation

> AI Analytics. FDA recall Z-1159-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1159-2021. Source: US FDA. Licensed CC0.

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