🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 12, 2024 Smith & Nephew Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smith & Nephew Inc.
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3097-2024

Related Recalls

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

Mar 18, 2025 Other Medical Devices Nationwide View Details →