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U.S. Department of Health and Human Services

Class 2 Device Recall Signature Ceramic Femoral ead

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  Class 2 Device Recall Signature Ceramic Femoral ead see related information
Date Initiated by Firm February 02, 2018
Create Date March 06, 2018
Recall Status1 Terminated 3 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/
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 2
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 and Original Applicant = SIGNATURE ORTHOPAEDICS, PTY, LTD