NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part number 00-5887-045-00 Lot number 62592928
  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:
Zimmer Trabecular Metal Technology, Inc.
Reason for Recall:
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA

Product Codes/Lot Numbers:

Part number 00-5887-045-00 Lot number 62592928

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0851-2015

Related Recalls

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Feb 1, 2019 Implants & Prosthetics Nationwide View Details →

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Feb 1, 2019 Implants & Prosthetics Nationwide View Details →

This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.

Jul 7, 2016 Implants & Prosthetics Nationwide View Details →