Class II — Potential Health Hazard

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

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of Recalled by Smith & Nephew Inc. Due to Product packaging process may result in an improper...

Date: August 12, 2024
Company: Smith & Nephew Inc.
Status: Ongoing
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 Smith & Nephew Inc. directly.

Affected Products

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201

Quantity: 2961 units (OUS)

Why Was This Recalled?

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smith & Nephew Inc.

Smith & Nephew Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

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