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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:134474

Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.

Official recall number

Z-1360-2015

Evidence summary

Product code
JWH
Recall status
Terminated
Event initiated
March 10, 2015
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1360-2015

Field note

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