FDA Medical Device Recalls (openFDA)
Signature Orthopaedics Europe Ltd: 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 number
- Z-1568-2020
- Recalling firm
- Signature Orthopaedics Europe Ltd
- 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
- Status
- Open, Classified
- Initiated
- 2019-10-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 5 components
- Distribution
- US: California
- Lot, serial or model codes
- Lot # 7DD49-1
- 510(k) numbers
- ["K161155"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 3014763043
- Firm city
- Athlone
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28