Class 2 Device Recall Zimmer Trabecular Metal Reverse Shoulder System Instrumentation

• Date Initiated by Firm: May 22, 2017
• Date Posted: September 22, 2017
• Recall Status: Terminated on March 29, 2019
• Recall Number: Z-3144-2017
• Recall Event ID: 77417
• 510(K)Number: K052906
• Product Classification: Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
• Product: Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
• Code Information: Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-372-4487
• Manufacturer Reason for Recall: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
• FDA Determined Cause: Process control
• Action: On 5/22/2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers and distributors. On 12/19/2017, Zimmer Biomet sent Urgent Medical Device Recall notices to their customers due to a recall expansion involving one (1) lot for product # 20. Customers are advised to review the notice and ensure that affected personnel are aware of the contents. All stock should be inspected and product quarantined. A Zimmer Biomet sales representative will remove the affected product from your facility. Customers should complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiomet.com and retain the copy for your files. Customers with questions may call the customer call center at 574-371-3071, Monday through Friday 8 am - 5 pm, EST. *For Distributors Your Responsibilities include the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of the completed acknowledgement form via email to: corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a copy of Attachment 3 Certificate of Sterilization with returned instruments. d. Mark the outside of the returns box(es) clearly with FIELD ACTION. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager Field Action Notice direc
• Quantity in Commerce: 2825 units
• Distribution: Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
• 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 = KWT and Original Applicant = ZIMMER, INC.