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-1114-2016
• Recall Event ID: 72900
• 510(K)Number: K833991
• Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
• Product: Product 16 consists of all product under poduct code: KWY and same usage:; Item no: ; 500103822 BIPOLAR LINER 38MM OD X 2; 500103922 BIPOLAR LINER 39MM OD X 2; 500104022 BIPOLAR LINER 40/41MM OD; 500104026 BIPOLAR LINER 40MM OD X 2; 500104222 BIPOLAR LINER 42/43 OD X; 500104226 BIPOLAR LINER 42MM OD X 2; 500104428 BIPOLAR LINER 44/45/46MM; 500104422 BIPOLAR LINER 44MM OD X 2; 500104426 BIPOLAR LINER 44MM OD X 2; 500104728 BIPOLAR LINER 47/48/49MM; 500104722 BIPOLAR LINER 47MM OD X 2; 500104726 BIPOLAR LINER 47MM OD X 2; 500104732 BIPOLAR LINER 47MM OD X 3; 500105028 BIPOLAR LINER 50/51/52MM; 500105022 BIPOLAR LINER 50MM OD X 2; 500105026 BIPOLAR LINER 50MM OD X 2; 500105328 BIPOLAR LINER 53/54/55MM; 500105322 BIPOLAR LINER 53MM OD X 2; 500105326 BIPOLAR LINER 53MM OD X 2; 500105728 BIPOLAR LINER 57/58MM OD; 500105722 BIPOLAR LINER 57MM OD X 2; 500106028 BIPOLAR LINER 60/62MM OD; 500106828 BIPOLAR LINER 68/70MM OD; 500106832 BIPOLAR LINER 68MM OD X 3; 500107228 BIPOLAR LINER 72MM OD X 2; 500103800 BIPOLAR SHELL 38MM OD; 500103900 BIPOLAR SHELL 39MM OD; 500104000 BIPOLAR SHELL 40MM OD; 500104100 BIPOLAR SHELL 41MM OD; 500104200 BIPOLAR SHELL 42MM OD; 500104300 BIPOLAR SHELL 43MM OD; 500104400 BIPOLAR SHELL 44MM OD; 500104500 BIPOLAR SHELL 45MM OD; 500104600 BIPOLAR SHELL 46MM OD; 500104700 BIPOLAR SHELL 47MM OD; 500104800 BIPOLAR SHELL 48MM OD; 500104900 BIPOLAR SHELL 49MM OD; 500105000 BIPOLAR SHELL 50MM OD; 500105100 BIPOLAR SHELL 51MM OD; 500105200 BIPOLAR SHELL 52MM OD; 500105300 BIPOLAR SHELL 53MM OD; 500105400 BIPOLAR SHELL 54MM OD; 500105500 BIPOLAR SHELL 55MM OD; 500105700 BIPOLAR SHELL 57MM OD; 500105800 BIPOLAR SHELL 58MM OD; 500106000 BIPOLAR SHELL 60MM OD; 500106200 BIPOLAR SHELL 62MM OD; 500107000 BIPOLAR SHELL 70MM OD; ; Product Usage:; For use in total or hemi hip 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: 8773
• 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 = KWY and Original Applicant = ZIMMER