Recalls for Greatbatch Inc.

Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements
03/12/2014 Medical Recall

Lack of sterility assurance has the potential to result in surgical infection.

  • Company:
    Greatbatch Inc.
Greatbatch, Inc. Issues Voluntary Field Corrective Action for Standard Offset Cup Impactor
03/11/2014 Food Recall

Greatbach, Inc. initiated a voluntary field corrective action for all Standard Offset Cup Impactors after an internal review determined that the sterilization recommendation in the Instructions for Use for the product did not meet requirements for sterility assurance, which has the potential to result in surgical infection. No incidents have been reported during clinical use of the product, nor have there been any reported adverse events.

  • Company:
    Greatbatch, Inc
  • Problem
    Sterilization recommendation in the Instructions for Use for the product did not meet requirements for sterility assurance