# FDA recall Z-3097-2024

> **Smith & Nephew Inc.** · Class II · device recall initiated 2024-08-12.

## Product

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

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).

## Key facts

- **Recall number:** Z-3097-2024
- **Recalling firm:** Smith & Nephew Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-12
- **Report date:** 2024-09-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3097-2024

## Citation

> AI Analytics. FDA recall Z-3097-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3097-2024. Source: US FDA. Licensed CC0.

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