FDA Medical Device Recall

Manufacturer: Zimmer Biomet, Inc.

Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate With Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder Products Are Indicated For Use In Patients Whose Shoulder Joint Has A Grossly Deficient Rotator Cuff With Severe Arthropathy And/or Previously Failed Shoulder Joint Replacement With A Grossly Deficient Rotator Cuff.

Recall Reason: The Product Was Potentially Being Packaged Without A Taper Adapter.

Recall Action:

The Firm, Zimmer Biomet, Sent An "URGENT MEDICAL DEVICE RECALL" Letters Dated 12/21/18 To Customers. The Letters Described The Product, Problem And Actions To Be Taken. The Customers Were Instructed To Do The Following: 1. Review This Notification And Ensure That Affected Personnel Are Aware Of The Contents. 2. If You Have Unconsumed Affected Product At Your Facility, Assist Your Zimmer Biomet Sales Representative And Quarantine All Affected Product. Your Zimmer Biomet Sales Representative Will Remove The Affected Product From Your Facility. 3. Complete Attachment 1  Certificate Of Acknowledgement And Send To CorporateQuality.PostMarket@zimmerbiomet.com. This Form Must Be Returned Even If You Do Not Have Affected Products At Your Facility. 4. Retain A Copy Of The Acknowledgement Form With Your Recall Records In The Event Of A Compliance Audit Of Your Facilitys Documentation. 5. If You Have Further 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. Calls Received Outside Of Call Center Operating Hours Will Receive A Voicemail Prompt Or Be Transferred To An On-call Representative In The Event Of An Emergency. Alternatively, Your Questions May Be Emailed To CorporateQuality.PostMarket@zimmerbiomet.com.

Recall Event Details

• Recall Date: 2019-03-01
• Date Initiated: 2018-12-21
• Date Created: 2019-03-01
• Reason for Recall: The Product Was Potentially Being Packaged Without A Taper Adapter.
• FDA Reason: Packaging Process Control
• Code Info: Lot Numbers 994110, 921950 UDI Numbers: (01) 0 0880304 53246 5 (17) 280920 (10) 994110 (01) 0 0880304 53246 5 (17) 280913 (10) 921950
• Quantity: 52
• Distribution: US Distribution To States Of:: AR, KY, And WA.; Internationally To: Australia And Japan.
• Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Contact Number: 574-371-3071
• Recall ID / Product ID: 167479 / 167479
• Recall Event ID: 81118
• Recall Number: Z-0972-2019
• Recall Class: FDA Class 2 Medical Device
• 501(k) Number: K120121
• Status: Open3, Classified
• Product Class: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Product Code: KWS