🔍 RecallPedia

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Class I - Dangerous
🏥 Medical Devices Recalled: December 14, 2021 Smith & Nephew Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 50971615, 50971617 & 50967788
  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:
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Product Codes/Lot Numbers:

Lot Numbers: 50971615, 50971617 & 50967788

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0635-2022

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.

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