Class 2 Device Recall Comprehensive Shoulder System Mini Humeral Stem 9mm

• Date Initiated by Firm: February 17, 2020
• Date Posted: March 03, 2020
• Recall Status: Terminated on May 31, 2022
• Recall Number: Z-1543-2020
• Recall Event ID: 85073
• 510(K)Number: K060692
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
• Product: Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
• Code Information: Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Kevin W. Escapule ; 574-371-3071
• Manufacturer Reason for Recall: A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
• FDA Determined Cause: Under Investigation by firm
• Action: URGENT MEDICAL DEVICE FIELD SAFETY NOTICE-REMOVAL letter dated February 17, 2020 was sent via email to consignees. The letter identified affected product, problem and the action to be taken. Customers were advised 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. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4.Complete Attachment 1  Certification of Acknowledgement Form and send to fieldaction.emea@zimmerbiomet.com.This form must be returned even if you do not have affected products available to return in your facility. 5.Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: ¿ Med Watch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by mail, or by fax. ¿ Online: www.fda.gov/medwatch/report.htm ¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm ¿ Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing product.experience@zimmerbiomet.com.
• Quantity in Commerce: 14 units
• Distribution: International distribution in the countries of Canada, Japan, Netherlands, South Korea.
• 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.