The Recall Desk

FDA (Devices) recall action 73498

Zimmer Manufacturing B.V. recalled 2 products on 2016-04-13

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-04-13
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-04-13

    Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

    Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product information on the box differed by sides, showing conflicting part and lot numbers.

    Product
    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
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2016-04-13

    Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

    Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product box displayed conflicting part and lot numbers on different sides.

    Product
    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
    Category
    Distribution
    19 states