Class 2 Device Recall Z1 Femoral Hip System

• Date Initiated by Firm: February 12, 2025
• Date Posted: March 24, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1329-2025
• Recall Event ID: 96348
• 510(K)Number: K233476
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: Z1 Femoral Hip System, Product Number 611777612
• Code Information: UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE RECALL notification dated 2/12/25 was sent to customers. Our records indicate that you may have received one or more of the affected products. The affected units were distributed between September 2024 and January 2025. Risk Manager Responsibilities: 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 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 recall notice and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 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 transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. For cases where the Z1 Offset Stem Inserter was used, increased clinical or radiographic monitoring may be required if the device fractured during use. If the Z1 Offset Stem Inserter was not used or if there was no evidence of fracture during use, there are no additional specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1
• Quantity in Commerce: 35 units
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LZO