The Recall Desk

FDA (Devices) recall action 62307

Synthes USA HQ, Inc. recalled 2 products on 2012-08-01

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
2012-08-01
Critical
0
Units
40

Why these products were recalled

Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

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

  • ModerateFDA (Devices)··2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling two lots of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a M
    Category
    Distribution
    15 states
  • ModerateFDA (Devices)··2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling 20 units of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a M
    Category
    Distribution
    15 states