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U.S. Department of Health and Human Services

Class 2 Device Recall Encina HA Femoral Stem

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  Class 2 Device Recall Encina HA Femoral Stem see related information
Date Initiated by Firm October 09, 2019
Create Date March 25, 2020
Recall Status1 Open3, Classified
Recall Number Z-1568-2020
Recall Event ID 85121
510(K)Number K161155  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
Product Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934
Code Information Lot # 7DD49-1
Recalling Firm/
Manufacturer		 Signature Orthopaedics Europe Ltd
Unit A, IDA Business & Technology Park
Garrycastle
Athlone Ireland
Manufacturer Reason
for Recall		 The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.
FDA Determined
Cause 2		 Labeling Change Control
Action On October 9, 2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via email to affected customers. In addition to informing the customers about the recall, the firm asked customers to take the following action: 1. Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall by forwarding this letter. 2. Please complete the attached Customer Acknowledgement Form and email it to us so that we may arrange for your stock to be recovered and replacement stock, or a credit note, issued. Please complete the Customer Acknowledgement Form even if you have no stock which is subject to recall, as we require this information to reconcile this process. Please complete this action within 2 weeks of the date on this letter to ensure the correction is implemented expeditiously. 3. This recall should be carried out to the hospital level. 4. For further information, please contact, christian Wight, christian@signatureortho.com.au
Quantity in Commerce 5 components
Distribution US: California
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 = MEH and Original Applicant = SIGNATURE ORTHOPAEDICS PTY LTD.
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