Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland
Lot Codes / Batch Numbers
Lot # 7DD49-1
Products Sold
Lot # 7DD49-1
Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland is recalling Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, F due to The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026