Class 2 Device Recall Comprehensive Shoulder System

• Date Initiated by Firm: October 10, 2018
• Create Date: December 07, 2018
• Recall Status: Terminated on April 28, 2020
• Recall Number: Z-0591-2019
• Recall Event ID: 81528
• 510(K)Number: K060692
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
• Product: Comprehensive Mini Stem, Item No. 113631:
• Code Information: 568150
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
• FDA Determined Cause: Under Investigation by firm
• Action: On October 10, 2018, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were advised of the product issue. Distributors were asked to take the following actions: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. If the affected product is located at a hospital, remove the product from the hospital and provide the Risk Manager Recall Notice to the hospital and request that they sign the Certificate of Acknowledgement. 4. Immediately return all affected product from your distributorship and from affected hospitals within your territory along with hospital Certificate of Acknowledgement. a. For each return, complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals included with the email notification sent to your facility. b. Identify whether there are any additional hospitals that Zimmer Biomet is not aware of and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. Hospital Risk Managers were asked to take the following actions: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your
• Quantity in Commerce: 3 total
• Distribution: Distributed to accounts in IN, MD, MO, MS, and NM.
• 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 = MBF and Original Applicant = BIOMET MANUFACTURING CORP.