# FDA recall Z-0662-2020

> **Paragon 28, Inc.** · Class II · device recall initiated 2018-09-28.

## Product

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

## Reason for recall

It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.

## Distribution

AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY  OUS: Australia & Israel

## Key facts

- **Recall number:** Z-0662-2020
- **Recalling firm:** Paragon 28, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-28
- **Report date:** 2019-12-18
- **Termination date:** 2020-08-20

- **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-0662-2020

## Citation

> AI Analytics. FDA recall Z-0662-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0662-2020. Source: US FDA. Licensed CC0.

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