FDA-Device2020-04-01Class II
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
Signature Orthopaedics Europe Ltd
Hazard
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.
Sold states
US: California
Affected count
5 components
Manufactured in
Unit A, IDA Business & Technology Park, Garrycastle, Athlone, N/A, Ireland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2020Don't want to check this manually?
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