Class 2 Device Recall Zimmer

• Date Initiated by Firm: January 11, 2016
• Date Posted: March 12, 2016
• Recall Status: Terminated on April 13, 2017
• Recall Number: Z-1149-2016
• Recall Event ID: 72900
• 510(K)Number: K872379
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Product 51 consists of all product under product code: JWH and same usage:; Item no: ; 598603701 NEXGEN OPTION STEMMED TIB; 598603702 NEXGEN OPTION STEMMED TIB; 598604701 NEXGEN OPTION STEMMED TIB; 598604702 NEXGEN OPTION STEMMED TIB; 598605701 NEXGEN OPTION STEMMED TIB; 598605702 NEXGEN OPTION STEMMED TIB; ; for use in total knee arthroplasty
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• Recalling Firm/ Manufacturer: Zimmer Manufacturing B.V.; Turpeaux Industrial Park Rd 1 km 123.4; Mercedita PR 00715
• For Additional Information Contact: Consumer Relations Call Center; 800-447-5633
• Manufacturer Reason for Recall: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
• FDA Determined Cause: Packaging
• Action: Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
• Quantity in Commerce: 29525
• Distribution: US Nationwide Distribution
• 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 = JWH and Original Applicant = ZIMMER, INC.