FDA recall Z-1568-2020

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

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.

Distribution

US: California

Key facts

Status

Ongoing

Initiation date

2019-10-09

Report date

2020-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athlone, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2020