# FDA recall Z-1776-2022

> **Paragon 28, Inc.** · Class II · device recall initiated 2022-07-13.

## Product

Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

## Reason for recall

Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

## Distribution

US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA.

## Key facts

- **Recall number:** Z-1776-2022
- **Recalling firm:** Paragon 28, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-13
- **Report date:** 2022-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Englewood, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2022

## Citation

> AI Analytics. FDA recall Z-1776-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1776-2022. Source: US FDA. Licensed CC0.

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