🔍 RecallPedia

Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

Class I - Dangerous
🏥 Medical Devices Recalled: December 10, 2018 Signature Orthopedics Pty Limited Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F
  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:
Signature Orthopedics Pty Limited
Reason for Recall:
Product mix up
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Genius Knee Cemented Tibial Component Product Usage: Knee replacement component

Product Codes/Lot Numbers:

UDI # 09348215020309 Device Model # 121-07-4004 Lot # 77A3F

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0833-2019

Related Recalls

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopedics Pty Limited

Class I - Dangerous

This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.

Feb 2, 2018 Implants & Prosthetics Nationwide View Details →