# FDA recall Z-0453-2022

> **Medshape, INC.** · Class II · device recall initiated 2021-11-17.

## Product

DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile

## Reason for recall

The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.

## Distribution

Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.

## Key facts

- **Recall number:** Z-0453-2022
- **Recalling firm:** Medshape, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-17
- **Report date:** 2022-01-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2022

## Citation

> AI Analytics. FDA recall Z-0453-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0453-2022. Source: US FDA. Licensed CC0.

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