Class 2 Device Recall Orthopedic Salvage System

• Date Initiated by Firm: April 03, 2018
• Create Date: April 25, 2018
• Recall Status: Terminated on July 02, 2018
• Recall Number: Z-1522-2018
• Recall Event ID: 79692
• 510(K)Number: K042409
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
• Code Information: Lot Number 360610, 333020
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• Manufacturer Reason for Recall: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Zimmer Biomet sent an Urgent Medical Device Recall letters to their affected customers. The letters identified the affected product, problem and the actions to be taken. Distributor Responsibilities: 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. Immediately return all affected product from your distributorship and from affected hospitals within your territory. 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. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transf
• Quantity in Commerce: 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf)
• Distribution: The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.
• 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 = HSB