# FDA recall Z-0104-2019

> **Valeris Medical, LLC** · Class II · device recall initiated 2018-07-16.

## Product

Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx.  The firm name on the label is Valeris Medical, Marietta, GA.

## Reason for recall

The product was mislabeled as containing the incorrect type of suture.

## Distribution

Distribution was made to FL, OH, OK, and TX,  Foreign distribution was made to the United Kingdom and New Zealand.

## Key facts

- **Recall number:** Z-0104-2019
- **Recalling firm:** Valeris Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-16
- **Report date:** 2018-10-24
- **Termination date:** 2020-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2019

## Citation

> AI Analytics. FDA recall Z-0104-2019. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0104-2019. Source: US FDA. Licensed CC0.

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