The Recall Desk

FDA (Devices) recall action 87924

Zimmer GmbH recalled 2 products on 2021-06-09

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
2021-06-09
Critical
0
Units
24

Why these products were recalled

Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-06-09

    Zimmer Natural Nail cephalomedullary device angle mismatch recall

    Zimmer GmbH is recalling its Cephalomedullary Short Nail due to potential mix-up between 125 and 130 degree CCD angle versions. Eight units with Lot 3020731 are affected and distributed to CA, GA, KY, MD, and internationally.

    Product
    Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2021-06-09

    Zimmer Femoral Nail Recall: Risk of Commingled Angle Versions

    Zimmer is recalling 16 units of its Natural Nail femoral implant due to potential commingling between two versions with different CCD angles (130 and 125 degrees). Wrong angle components could result in improper fracture fixation.

    Product
    Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
    Category
    Distribution
    4 states