Class 2 Device Recall Zimmer

• Date Initiated by Firm: December 17, 2014
• Date Posted: February 20, 2015
• Recall Status: Terminated on September 23, 2015
• Recall Number: Z-1133-2015
• Recall Event ID: 70401
• 510(K)Number: K033634
• Product Classification: Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
• Product: Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
• Code Information: Item numbers: 19.32.05; 19.32.06; 19.32.08; Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398
• Recalling Firm/ Manufacturer: Zimmer Gmbh; Sulzer Allee 8; Winterthur Switzerland
• For Additional Information Contact: Consumer Relations Call Center; 800-447-5633
• Manufacturer Reason for Recall: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
• FDA Determined Cause: Package design/selection
• Action: On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. 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. For questions, call the customer call center at 1-800-348-2759.
• Quantity in Commerce: 30
• Distribution: Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
• 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 = KWA and Original Applicant = CENTERPULSE ORTHOPEDICS, INC.