Class 2 Device Recall Signature Ceramic Femoral ead

• Date Initiated by Firm: February 02, 2018
• Create Date: March 06, 2018
• Recall Status: Terminated on August 08, 2018
• Recall Number: Z-0920-2018
• Recall Event ID: 79219
• 510(K)Number: K121297
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
• Product: Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
• Code Information: UDI: 09348215001926. Lot:78560.
• Recalling Firm/ Manufacturer: Signature Orthopedics Pty Limited; 7 Sirius Road; Lane Cove West; Sydney Australia
• Manufacturer Reason for Recall: This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
• FDA Determined Cause: Labeling mix-ups
• Action: Signature Orthopaedics notified customer(s) of the recall by sending an Urgent Medical Device Recall Letter dated February 2, 2018 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Acknowledgement Form and firm's Effectiveness Check Questionnaire.
• Quantity in Commerce: 10
• Distribution: Worldwide Distribution - U.S. Nationwide and the country of Australia.
• 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 = MEH