# FDA recall Z-1572-2022

> **SAFE ORTHOPAEDICS LLC** · Class II · device recall initiated 2022-06-03.

## Product

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers   KITM640, KITM645, and KITM740.

## Reason for recall

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

## Distribution

Distribution was made to MD.  There was no government/military distribution.

## Key facts

- **Recall number:** Z-1572-2022
- **Recalling firm:** SAFE ORTHOPAEDICS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-06-03
- **Report date:** 2022-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1572-2022

## Citation

> AI Analytics. FDA recall Z-1572-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1572-2022. Source: US FDA. Licensed CC0.

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