Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

WishBone Medical Plate and Screw System - Screw Recalled by Wishbone Medical, Inc. Due to Nonconformities were discovered to the engineering specifications for...

Date: April 30, 2021
Company: Wishbone Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Wishbone Medical, Inc. directly.

Affected Products

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

Quantity: 60 products

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 3 states: IN, PA, VA

Affected (3 states)Not affected

About Wishbone Medical, Inc.

Wishbone Medical, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report