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
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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