# FDA recall Z-1138-2021

> **DeRoyal Industries Inc** · Class II · device recall initiated 2021-01-25.

## Product

CV Basin Set Pack, REF numbers:  a) 89-7935.11   b) 89-7935.12  c) 89-7935.13  d) 89-7935.14  e) 89-7935.15  f) 89-7935.16      Custom surgical procedure packs including sternum saw blades.

## Reason for recall

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

## Distribution

Distributors in OK, MI, and TX.

## Key facts

- **Recall number:** Z-1138-2021
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-25
- **Report date:** 2021-03-03
- **Termination date:** 2022-07-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2021

## Citation

> AI Analytics. FDA recall Z-1138-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1138-2021. Source: US FDA. Licensed CC0.

---

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