Class 2 Device Recall CoCr Femoral Head

• Date Initiated by Firm: February 27, 2023
• Date Posted: March 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1294-2023
• Recall Event ID: 91842
• 510(K)Number: K993259
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
• Code Information: GTIN Number: 00889024283268 All lots
• 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: Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
• FDA Determined Cause: Under Investigation by firm
• Action: Zimmer Biomet issued Urgent Medical Device Correction letter on 2/27/23 via Fed'X .Letter to Distributors, Doctors, Risk Managers and states reason for recall, health risk and action to take: Hospital Responsibilities: 1. Review this field action notice and ensure that affected personnel are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement Form and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 3. Retain a copy of the Attachment 1 Certificate of Acknowledgement Form with your field action notice records in the event of a compliance audit of your facility s documentation. 4. 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 field action notice for awareness of the contents. 2. There are no specific patient monitoring instructions related to this notice that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement Form and send to CorporateQuality.PostMarket@zimmerbiomet.com . 4. Retain a copy of the Attachment 1 Certificate of Acknowledgement Form with your field action notice records in the event of a compliance audit of your facility s documentation. 5. 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
• Quantity in Commerce: 1,168 untits
• Distribution: AL AZ CO FL LA MI OH OK TX Foreign: Canada
• 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 = LPH