# FDA recall Z-0325-2018

> **Amendia, Inc** · Class II · device recall initiated 2017-07-07.

## Product

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

## Reason for recall

Incorrect labeling for the lot of MAC Pins.  Although the pins are laser as  460  mm in length, the pins are 60 mm in length.

## Distribution

Distribution to Georgia, USA.

## Key facts

- **Recall number:** Z-0325-2018
- **Recalling firm:** Amendia, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-07
- **Report date:** 2018-01-17
- **Termination date:** 2019-10-15

- **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-0325-2018

## Citation

> AI Analytics. FDA recall Z-0325-2018. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0325-2018. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
