Z-1568-2020Class II

Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use...

Name: Z-1568-2020 Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use...
Creator: Signature Orthopaedics Europe Ltd
Published: 2019-10-09
License: https://open.fda.gov/license/

Signature Orthopaedics Europe Ltd / initiated 2019-10-09 / Open, Classified / root cause: labeling and UDI

FDA source

Signature Orthopaedics Europe Ltd began a recall of 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... on 2019-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1568-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-09
Posted: 2020-03-25
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
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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.
Root cause tag: labeling and UDI
FDA 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, [email protected]
Quantity in commerce: 5 components
Distribution: US: California
Product codes and lots: Lot # 7DD49-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1568-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1568-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-25

Product code MEH

K161155Class IIOrigin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd. / cleared 2016-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)