Class 2 Device Recall Anatomical Shoulder" Domelock

• Date Initiated by Firm: May 17, 2016
• Create Date: June 16, 2016
• Recall Status: Terminated on October 31, 2016
• Recall Number: Z-2003-2016
• Recall Event ID: 74206
• 510(K)Number: K142403
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
• Product: Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0.; The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning.; The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
• Code Information: Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862
• Recalling Firm/ Manufacturer: Zimmer Gmbh; Sulzer Allee 8; Winterthur Switzerland
• For Additional Information Contact: Customer Service; 800-348-2759
• Manufacturer Reason for Recall: In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
• FDA Determined Cause: Device Design
• Action: Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL  LOT SPECIFIC notification dated May 17, 2016, to all affected consignees via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Consignees were instructed to review the notification and ensure affected personnel were aware of the contents. Assist their Zimmer Bioment sales representative with the quarantine of any affected product from the table above. Complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com. If after reviewing this notification consignees have further questions or concerns please call the customer call center at 1- 800-348-2759 between 8:00 am and 8:00 pm EST.
• Quantity in Commerce: 177
• Distribution: Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWS and Original Applicant = ZIMMER GMBH