# FDA recall Z-0010-2021

> **Riverpoint Medical, LLC** · Class II · device recall initiated 2020-08-03.

## Product

Velosorb Fast Braided Absorbable Suture:  Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

## Reason for recall

The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0010-2021
- **Recalling firm:** Riverpoint Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-03
- **Report date:** 2020-10-07
- **Termination date:** 2022-09-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2021

## Citation

> AI Analytics. FDA recall Z-0010-2021. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/Z-0010-2021. Source: US FDA. Licensed CC0.

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