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FDAMarch 17, 2016device

Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

What to do

FDA enforcement status: Terminated

Brands named

zimmer manufacturing b vzimmerzimmer manufacturing

UPCs

42511400818

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18 — Recall Details · AllClear