FDAMarch 17, 2016device
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14
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
42511400514
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 1100404762026-05-20
- FDAOff-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 1100402402026-05-20
- FDAOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402412026-05-20
- FDAOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402422026-05-20
- FDABrand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A2026-05-11
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