Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog number 18220930S and Lot Code K836729
  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:
Stryker Howmedica Osteonics Corp.
Reason for Recall:
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions

Product Codes/Lot Numbers:

Catalog number 18220930S and Lot Code K836729

Distribution:

Distributed in: US, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2791-2016

Related Recalls

Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.

Apr 26, 2017 Implants & Prosthetics Nationwide View Details →

Reunion TSA Peg Alignment Sound broke during surgery.

Dec 2, 2016 Implants & Prosthetics Nationwide View Details →

A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.

Nov 9, 2016 Other Medical Devices Nationwide View Details →