# FDA recall Z-1794-2021

> **Wishbone Medical, Inc.** · Class II · device recall initiated 2021-04-30.

## Product

WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut.   Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US

## Reason for recall

Nonconformities were discovered to the engineering specifications for implant plates and screws.

## Distribution

Domestic: VA, PA, IN.

## Key facts

- **Recall number:** Z-1794-2021
- **Recalling firm:** Wishbone Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-30
- **Report date:** 2021-06-16
- **Termination date:** 2022-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2021

## Citation

> AI Analytics. FDA recall Z-1794-2021. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1794-2021. Source: US FDA. Licensed CC0.

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