FDA Medical Device Recall

Manufacturer: Zimmer Biomet, Inc.

Biomet Small Diameter Cement Plug Inserter-Sterile, Single-use Accessory Instrumentation To Be Used During Surgical Procedures Utilizing The Small Diameter Cement Plug Implant DevicesItem Number: 414989

Recall Reason: Lack Of An Adequate Sterilization Validation

Recall Action:

Zimmer Biomet Issued Recall Letter On 2/28/19 Via FedEx And Email Identifying Reason For Recall To The Consumer/user Level, Including Any Intermediate Wholesale Or Retail Consignees. Distributors Responsibilities Include Locating And Removing The Product In Their Territory, As Well As Identifying Hospitals And Surgeons Who Have Previously Used The Product. " Distributors Will Return On-hand Product To Zimmer Biomet And Ensure All Of Their Products Are Accounted For Using The Form Provided In The Letter. " Surgeons Provided With A Letter That Identifies The Issue And Their Responsibilities, Which Include: - Following Any Specified Patient Monitoring Instructions - Returning Certificate Of Acknowledgment To Zimmer Biomet. " Hospital Risk Managers Provided With A Letter Identifying The Issue And Their Responsibilities. Questions Or Concerns After Reviewing This Notice, Please Call Customer Service At 574-371-3071 Between 8:00 Am And 5:00pm EST, Monday Through Friday

Recall Event Details

• Recall Date: 2019-04-01
• Date Initiated: 2019-02-28
• Date Created: 2019-04-01
• Reason for Recall: Lack Of An Adequate Sterilization Validation
• FDA Reason: Process Design
• Code Info: All Lots
• Quantity: 89 Units
• Distribution: Nationwide
• Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Contact Number: 411 Technical Services574-371-
• Recall ID / Product ID: 171355 / 171355
• Recall Event ID: 82324
• Recall Number: Z-1081-2019
• Recall Class: FDA Class 2 Medical Device
• 501(k) Number: K033280
• Status: Open3, Classified
• Product Class: Dispenser, Cement
• Product Code: KIH