The Recall Desk

FDA (Devices) recall action 62943

Synthes USA HQ, Inc. recalled 2 products on 2013-02-13

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
2013-02-13
Critical
0
Units
111

Why these products were recalled

Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

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)··2013-02-13

    Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk

    Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the ce
    Category
    Distribution
    52 states
  • HighFDA (Devices)··2013-02-13

    Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage

    Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterio
    Category
    Distribution
    52 states